Understanding rare solid tumors and their genetic factors
Natural History and Biospecimen Acquisition Study for Children and Adults With Rare Solid Tumors
National Institutes of Health Clinical Center (CC) · NCT03739827
This study is looking to learn more about rare solid tumors and their genetic factors by collecting samples and medical histories from people who have these tumors to help improve future treatments and prevention.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 4 Weeks and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | radiation |
| Locations | 3 sites (Bethesda, Maryland and 2 other locations) |
| Trial ID | NCT03739827 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the natural history and genetic characteristics of rare solid tumors by collecting biological samples and medical histories from affected individuals. Participants will be screened based on their medical and family histories, and those with rare tumors will have their medical records reviewed. The study seeks to gather valuable data that could lead to improved screening, prevention, and treatment strategies for rare cancers.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with rare solid tumors, those with a family history of such tumors, or individuals with genetic variants predisposing them to rare tumors.
Not a fit: Patients with common solid tumors or those without any genetic predisposition to rare tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of rare solid tumors, leading to better screening and treatment options for patients.
How similar studies have performed: Previous studies on rare tumors have shown that even non-interventional research can lead to significant advancements in understanding and treating these conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Cohort 1: Participants with a diagnosis of a rare solid tumor (fewer than 15 cases in 100,000 people per year). There are no age restrictions beyond the neonatal period (4 weeks). OR -Cohort 2: Participants without a rare tumor who have a germline genetic variant that predisposes to a rare solid tumor OR -Cohort 3: Relatives of participants with diagnosis of rare solid tumors who do NOT have a known germline variant that predisposes to a rare solid tumor OR * Cohort 4: Parent/guardian of child participating in a focus group if not already enrolled on the study. * Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: None
Where this trial is running
Bethesda, Maryland and 2 other locations
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
- Oregon Health and Science University — Portland, Oregon, United States (RECRUITING)
- Texas Children's Hospital — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Mary F Wedekind Malone, D.O. — National Cancer Institute (NCI)
- Study coordinator: Barbara J Thomas, R.N.
- Email: barbara.thomas2@nih.gov
- Phone: (240) 858-3633
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Solid Tumors, Other Neoplasms Solid Tumors, Pediatric Solid Tumor, Refractory Solid Tumors, Solid Tumor, Service to the Patients, Knowledge about the Nature of Cancer, Cancer Evaluations