NCT03050268Recruiting
Familial Investigations of Childhood Cancer Predisposition
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 8 Feb 2017
- Start date
- 6 Apr 2017
- Primary completion date
- 31 Mar 2037
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Hodgkin lymphoma, Neuroblastoma, Myelodysplastic syndromes, Melanoma, Pancreatic cancer, Ovarian cancer, Acute myeloid leukemia, Childhood cancers, Sarcoma
- NCT number
- NCT03050268
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 6 Apr 2017 to the primary completion date, 31 Mar 2037
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- An inability or unwillingness of the research participant or his/her legally authorized representative (LAR) to provide written informed consent.
Who the study is looking for
- 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.
Criteria the registry did not label
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.