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Familial Investigations of Childhood Cancer Predisposition

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer."
  • "During the study, blood samples or other healthy tissue will be obtained from participants, as well as medical and family histories."
  • "A blood sample will be drawn at St."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for gene changes that may raise cancer risk in families, including families with childhood cancer. It collects health records, blood, and sometimes leftover tumor samples from people who qualify and their blood relatives. This research does not replace medical genetic testing, and families may get results years later or never.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You may qualify if any one of the following applies to you, or if you are a blood relative of someone who qualifies. Blood relatives can join with or without cancer.
  • You had cancer before age 26 and have a first, second, or third degree blood relative, such as a parent, grandparent, or first cousin, who had cancer before age 51.
  • You have had more than one cancer, with at least one diagnosed before age 26.
  • You have a known condition that raises cancer risk, diagnosed by a medical exam or genetic testing.
  • You had cancer present at birth that was diagnosed before age 6 months.
  • You had a rare childhood cancer or tumor diagnosed before age 26.
  • Adult cervical cancer linked to HPV (a virus) and adult skin cancer other than melanoma do not count toward these cancer-history rules.
  • If you meet these rules, you may join even if you already had medical genetic testing, no matter what the results were.

Who can't join

  • You or your legal representative cannot or will not give written consent to join.
  • You had a bone marrow transplant from a donor, have no DNA sample from before the transplant that is free of cancer, and will not give a skin sample.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 individual meeting this protocol's definition of "Familial Cancer," who are either affected or unaffected by cancer. EXCLUSION CRITERIA: * An inability or unwillingness of the research participant or his/her legally authorized representative (LAR) to provide written informed consent. * The participant has received allogeneic bone marrow transplantation and has NO pre-transplant germline (cancer-unaffected) DNA available AND is unwilling to provide a skin sample.

Study sites (1)

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