Familial Investigations of Childhood Cancer Predisposition (NCT03050268) | Clinical Trial Compass
RecruitingNot Applicable
Familial Investigations of Childhood Cancer Predisposition
United States1,500 participantsStarted 2017-04-06
Plain-language summary
NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing.
While it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition.
The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer.
PRIMARY OBJECTIVE:
* Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members.
SECONDARY OBJECTIVE:
* Identify novel cancer predisposing genes and/or genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown below, you may enroll regardless of the results of your clinical genetic testing.
DEFINITION OF FAMILIAR CANCER FOR THIS PROTOCOL:
In this protocol, the definition of "Familial Cancer" is met if any of the following is present:
* An individual with a history of cancer diagnosed under 26 years of age who has at least one first, second or third degree relative with a history of cancer diagnosed under 51 years of age; OR
* An individual who has been diagnosed with more than one cancer, at least one of which was diagnosed under 26 years of age; OR
* An individual with a clinical or molecular diagnosis of a known cancer predisposition syndrome; OR
* An individual with a congenital cancer diagnosed before 6 months of age; OR
* An individual with a rare pediatric cancer or tumor diagnosed before 26 years of age
º Excluding human papilloma virus-associated cervical cancer and non-melanoma skin cancer occurring in adults.
INCLUSION CRITERIA:
* An individual who meets this protocol's definition of "Familial Cancer," as above.
* Biologic relatives of an i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on finding new cancer predisposing genes rather than testing a treatment, can you help me understand whether participating would actually change my child's current care plan, or is this more about contributing to future research?
2Given that our family seems to have a pattern of one of these conditions — like Li-Fraumeni Syndrome or Lynch Syndrome — would joining this study mean our whole family gets genetic testing, and how would unexpected findings about other relatives be handled?
3Because this is labeled 'Phase NA,' it's a research registry or genetic study rather than a drug trial — so what exactly would be collected from us, like blood samples or medical records, and what ongoing commitment would that require from our family?
4If the researchers do identify a gene variant in our family through this study, how would we be told about it, and would that information be shared with our regular doctors in a way that could affect insurance or employment?
5Before enrolling in a study like this, should we first complete standard genetic counseling on our own, or is that something this trial would provide as part of participation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of novel cancer predisposing genes
Timeframe: Up to 20 years following study activation