FAQs  

Frequently Asked Questions

About

What is the PCROWD study?


The PCROWD study is a tissue and clinical data bank. It is part of the Center for Prevention of Progression of Blood Cancers (CPOP) at Dana-Farber Cancer Institute.




How can I speak with someone if I need help enrolling?


You can contact the study team via email at precursor@partners.org or by phone at 617-582-8664.




What is the purpose of this study?


The purpose of this study is to collect samples and clinical data from people who have been diagnosed with early phases of blood conditions that may develop into cancer. We call these precursor conditions.





Samples and Data

What types of samples does the PCROWD study collect?


We ask that you send us a blood sample every time you get a sample drawn that has been ordered by your doctor to follow your precursor condition. If your doctor orders a bone marrow biopsy as part of your clinical care, we would also ask you give us a sample. This bone marrow sample and all blood samples should only be taken after the samples obtained for your care. We may also collect a saliva sample and would let you know if we need a sample from you.




Why does the PCROWD study want my samples?


We are creating a sample bank with samples collected from people diagnosed with blood cancer precursor conditions. Your samples, and those of other participants, are a valuable resource that is available to researchers leading innovative experiments that will transform the future of people who have been diagnosed with these conditions and those have developed active blood cancer.




How long will my samples be stored?


Your samples will be sent to a secure lab. There is no time limit for how long we will store your samples. If you stop your participation in the study, your samples will not be discarded.




If I'm not comfortable giving a sample, can I still participate?


Yes. You are welcome to participate and provide us with information regarding your diagnosis as well as information regarding your medical history, lifestyle, health habits, and family history.




What kind of information could be found in this study and will I be able to see it?


This study is being done to add to our knowledge of how genes and other factors affect cancer. We are gathering this knowledge by studying groups of people, and the study is not meant to test your personal medical status. For that reason, we will not give you the results of our research on your samples. However, we will post information on our website regarding key discoveries that we make about precursor conditions, overall results, and progress made through this research.




Who will use my samples and see my information?


Your samples and information will be available to researchers at the Dana-Farber/Harvard Cancer Center who have approval from the DFCI Institutional Review Board to use your samples and health information for research that is conducted under this study. Your samples may be shared with other places, such as the institutions that may conduct the sequencing. No information that could identify you will be sent with your samples. In addition, if you agree, we will share your results with central data repositories (such as the National Institutes of Health), which may share information without your permission. Your name or other directly identifiable information would not be provided to these central repositories.




Does my sample need to be sent on the same day it is drawn?


Yes. We must receive your sample within 24 hours after it was drawn so that it is viable for processing at the lab. Samples should be collected between Monday and Thursday and should be shipped to the study team on the same day they are drawn.




How often do I need to send a blood sample?


How often we receive a sample from you will depend on how often your doctor is following you for your precursor condition. In general, we expect to receive a sample from you every 6 months. However, if you are only followed every 12 months, you can send us a sample every 12 months. Participants who have been diagnosed with smoldering multiple myeloma or smoldering Waldenstrӧm Macroglobulinemia who are followed every 3 months can send us a blood sample with that frequency.




Do I have to send you a bone marrow sample to participate in this study?


No. We will only collect a bone marrow sample from you if you and your doctor agree that you should get a bone marrow biopsy as part of your clinical care. This sample should only be drawn after your clinical sample has been drawn. Please contact the study team two weeks prior to your bone marrow biopsy appointment to request a bone marrow collection kit.




Where do I go to draw my sample?


Because your samples will be collected at the same time as the samples that are drawn to follow your precursor condition, research samples will be collected where you currently get your clinical samples drawn. For example, this can be at your doctor’s office or at the lab where you usually get your samples drawn.




What is the process to get my sample drawn?


When you attend your blood draw appointment, ask the lab technician to draw a courtesy research sample after drawing your clinical sample. The research test tubes can be attached to the same needlestick point. Samples should be collected between Monday and Thursday and should be shipped to the study team on the same day they are drawn.

You will be provided with all the materials to package and ship your samples. Follow the packaging instructions to package your sample. To ship the sample, call FedEx to pick up the sample(s) at your house. You can also drop them off at the nearest FedEx office. Sending the sample will not cost you anything as the prepaid air bill is included with the collection kit.




How do I send you my sample and will it cost me anything to do so?


To ship the sample, call FedEx to pick up the sample(s) at your house. You can also drop them off at the nearest FedEx office. Sending the sample will not cost you anything as the prepaid air bill is included with the collection kit.




What happens if I forget to take the sample collection kit with me on the day of the sample draw appointment?


Check the expiry date on the test tubes. The expiry date is identified by an hourglass icon and either located on a sticker pasted on the test tube or is printed in gray directly on the tube. If the tubes are set to expire before your next regular blood draw appointment, please request another collection kit through the participant portal or contact the study team two weeks prior to your appointment. Discard the expired test tubes and send the extra packaging and shipping materials together with your next sample.




What types of research projects will researchers do with my samples and health information?


Examples of the studies that may be done include, but are not limited to: studies that will help us understand how cancer forms within the body, studies that will examine whether certain genes or DNA sequences protect or predispose people to developing cancer, and studies that will help with the development of new cancer drugs. Some of these studies may be published. You will not be identified in publications without your permission.




Do I need to send you my medical records?


We need your medical records to properly annotate the history of your precursor condition. We will ask you or your medical provider to give us a copy of your medical records pertaining your precursor condition starting with diagnosis and continuing with the records of your regular follow up appointments. These records can include any of the following: clinic visit notes, operative reports, discharge summaries, radiology/imaging, pathology reports, radiation reports, lab reports, photographs, and other records related to your precursor condition. We will gather your records until you come ‘off study’.




How do I send you my medical records?


Although we ask for your authorization to contact your local medical providers to obtain your medical history pertaining your precursor condition, you can also send us your records directly to precursor@partners.org, by secure fax to 617-394-2603, or by mail to PCROWD Study, 450 Brookline Ave., Boston, MA 02215.




Can I send you my medical records directly instead of authorizing you to contact my medical providers?


Yes, you can send us your records directly to precursor@partners.org, by secure fax to 617-394-2603, or by mail to PCROWD Study, 450 Brookline Ave., Boston, MA 02215.





Privacy

What will you do to protect my privacy?


Answer here.We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data.

Federal law requires that we protect the privacy of the information that identifies you. If you agree to participate in this study, you are authorizing us to access and use your private information.

Your samples may be shared with other places, such as institutions that may conduct sequencing. No information that could identify you will be sent with your samples.

The results of this research study may be published. You will not be identified in publications without your permission.




What will you do with my email address or phone number?


We may call you or email you about the PCROWD study. We may also contact you to let you know about other research studies available to you. We may reach out to you for updates or to ask you to complete additional study surveys.

You can tell us your preferred contact method.




Will you sell my email address or phone number?


No, we will never sell your email address or phone number.




Who can see the information I give the PCROWD study?


Only researchers approved by the PCROWD study will be allowed to see data from individual participants. These researchers may be from anywhere in the world. They may work for commercial companies. Other researchers may include the National Institutes of Health (NIH) and other organizations that have developed special information banks that analyze data and collect the results of certain types of genetic studies. Your information may also be shared with Dana-Farber Cancer Institute offices that deal with research oversight. However, your information or samples will only be sent with a study code number. Your name or other directly identifiable information will not be shared with these repositories or with other researchers.





Follow-Up Care

Will this study be involved in my ongoing medical care?


The PCROWD study is a research effort. We will not be involved in your medical care.




Will I need to see a certain doctor for follow up care?


No. You can continue seeing the same doctor that is following you for your precursor condition.





For Healthcare Providers

What is involved for Healthcare Providers when patients join this study?


We will be contacting you, with the patient’s authorization, to ask for their clinical history regarding the precursor condition they have been diagnosed with. Clinical history documents include: clinic visit notes, operative reports, discharge summaries, radiology/imaging, pathology reports, radiation reports, lab reports, photographs, and other records related to your patient’s precursor condition.

We also ask your support in ensuring that your patient does not have issues when asking the lab technician to draw the research sample. It is important to note that participants will not undergo tests or procedures that are not required as part of their routine clinical care. They will only be asked to provide an additional sample from tissue that is obtained for clinical indications. Your patient has agreed to these arrangements and will need the following to be drawn during their regularly scheduled visits: 30-60 cc of peripheral blood and/or 5-20 cc of bone marrow. If applicable, they will also be asked to donate a buccal sample. Participants will bring all required materials for packaging and shipping the sample(s) to us.




Do you want healthcare providers to refer patients to this study?


Yes. Our goal is to recruit 10,000 participants. By informing eligible patients about this study, you are helping us reach our goal.





Eligibility

Who is eligible to participate in the PCROWD study?


People who have been diagnosed with a precursor condition are eligible to participate in this study. See Who can join? for more information.




Do I have to be living in the United States to participate in the PCROWD study?


No. Eligible people are welcome to get registered to the study and submit their information. However, only people living in the United States can submit their samples for now.




Can I join the study if I don’t have a computer or internet access?


Yes. You can contact the study team by calling 617-582-8664 to request a paper copy of the study registration documents.




Is having an email address required?


Having an email is required to get registered online. If you get registered online, you will also have access to the participant portal, where you can see your study registration information and update relevant data.

If you do not wish to get registered online, you also have the option to contact the study team by calling 617-582-8664 and they will be happy to send you the paper forms to get registered to the study.





Participation

What will you ask me to do?


We will ask you to share different types of information such as basic information about yourself, information about your diagnosis (including access to your medical health record), and information about your medical history, lifestyle, health habits, and family history. We will also ask you to provide samples at regular intervals. As part of your continued participation in the study, we may ask you to answer additional surveys.




If I am already enrolled in another study, can I still join the PCROWD study?


Yes. Participating in other studies, including clinical trial studies, does not exclude you from participating in the PCROWD study.




Is the study open to international participants?


Yes. If you live outside of the United States, you are welcome to get registered to the PCROWD study. The information you provide at registration, including completing the study surveys, are important to our understanding of precursor conditions. You do not need to provide samples for now. We will notify you when this option is available to international participants.




Does it cost anything to join?


Joining the PCROWD study is free. There are no costs to you or your insurance. Also, all sample packaging and shipping materials will be given to you to collect your sample. You will not need to pay for sending us your sample.




Will I benefit from participating in this study?


This study will not benefit you directly. However, the information we learn from you and others who participate will help future patients with blood cancers and people who are at risk of developing those diseases.




Will I be paid?


No. You will not be paid to participate in the PCROWD study. We may use your samples and information to develop a new product or medical test to be sold. The sponsor and hospital may benefit if this happens. You will not be paid if your samples are used for this purpose.




Will the PCROWD study team communicate directly with my health care team?


With your authorization, we will contact your health care team to request copies of your medical health records related to your precursor condition. Alternatively, you can also send us your records directly to precursor@partners.org or by secure fax to 617-394-2603.




How often will I hear from the study team?


We may contact you to ask you to complete additional study surveys. We may also contact you if we have questions regarding your registration or other information you have provided.

We will post study updates in the News section of the PCROWD study website. You are also welcome to contact the study team at any time.




Will researchers contact me directly?


No. The PCROWD study staff will be the only ones contacting you about the study.




Will my health information be shared with any insurance companies (health, life, disability, etc.)?


No. We take your privacy very seriously and will take great care to protect it.




Are there risks to me if I participate in this study?


The main risk of participating in this study is that your information or the information obtained from studying your samples, could be seen by unauthorized individuals. We have lowered this risk by setting strict controls on access to databases that store your information. There may be other privacy risks that we have not foreseen. While we believe the risks to you and your family are very low, we are unable to tell you exactly what all the risks are.

There are small risks related to drawing samples. You may experience slight pain and swelling at the site of the draw.




Can I stop being on the research study?


You can stop your participation at any time. To do so, please write an email to precursor@partners.org or send a letter to the study contact. Any samples you provided will not be discarded and will remain in the PCROWD tissue bank.




How long will my participation in the PCROWD study last and when would I come ‘off study’?


How long people participate in the PCROWD study will vary from one person to another. Participants in the PCROWD study will be followed until they progress to active blood cancer or until they decide to end their participation.

Many people with precursor conditions do not develop active disease. However, those who do progress from a precursor condition to active blood cancer requiring therapy would no longer be eligible to continue their participation in the study and would come ‘off study’. You may be contacted in the future about other research studies that might be relevant to you.

Participants who come ‘off study’ due to progression will be followed once a year. Participants who decide to end their participation will no longer be contacted by the PCROWD study team.




What if I have questions regarding the study?


If you have any questions, call 617-582-8664 or email precursor@partners.org.





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