Collecting and storing samples from children and adults with common childhood cancers
Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
This study is collecting and storing samples from children and adults with common childhood cancers to help researchers learn more about these diseases and find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6035 (estimated) |
| Ages | 4 Weeks and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 5 sites (Washington D.C., District of Columbia and 4 other locations) |
| Trial ID | NCT01109394 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a comprehensive tissue repository for pediatric solid tumors and related biological studies. It involves collecting and storing blood, serum, tissue, urine, or tumor samples from individuals diagnosed with common childhood cancers, including sarcoma, neuroblastoma, and others. The study will also include systematic molecular, genomic, and proteomic profiling of the collected specimens to enhance understanding of cancer biology and improve treatment options. Participants may include patients of any age with a cancer diagnosis, their biological relatives, and healthy volunteers undergoing routine procedures.
Who should consider this trial
Good fit: Ideal candidates include individuals of any age diagnosed with common childhood cancers or their biological relatives.
Not a fit: Patients without a history of malignancy or familial cancer syndromes may not receive direct benefits from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment of pediatric cancers through enhanced biological insights.
How similar studies have performed: Other studies utilizing tissue repositories and omics profiling have shown promise in advancing cancer research, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
* SUBJECT INCLUSION CRITERIA: Pediatric or adult subjects with one of the following: * Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected premalignant familial syndromes, regardless, of patient age; * Biological relatives of any patient with a tumor, malignancy, pre-malignant disorder, or suspected familial pre-malignant syndrome, regardless of patient age or the diagnosis of an adult malignancy or pre-malignant disorder; * Healthy Volunteer without history of malignancy nor a family member currently being treated for cancer who are undergoing surgery, treatment or during well visits; * Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care. * Human samples, specimens and data collected on IRB approved protocols that are now closed * Ability of subject, Legally Authorized Representative (LAR), or parent/legal guardian of children \<=18 to understand and be willing to sign an IRB-approved informed consent document that permits the use of the tumor and other samples for genomic-based molecular characterization projects. Inclusion Criteria for Social and Behavioral Outcome Interviews: * Parent/caregiver of a participating pediatric or adult patient who is being treated for, or who has previously been treated for any form of pediatric cancer. * Must be able to give consent and sign the informed consent document. * Able to understand the English language. EXCLUSION CRITERIA: None
Where this trial is running
Washington D.C., District of Columbia and 4 other locations
- Children's National Medical Center — Washington D.C., District of Columbia, United States (Completed)
- Children's Hospital of Orange County (CHOC Children's) — Orange, Florida, United States (Withdrawn)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
- Tisch Cancer Institute, Mount Sinai Medical Center — New York, New York, United States (Withdrawn)
- Carolinas Medical Center/Levine Children's Hospital — Charlotte, North Carolina, United States (Withdrawn)
Study contacts
- Principal investigator: Rosandra N Kaplan, M.D. — National Cancer Institute (NCI)
- Study coordinator: Donna B Bernstein, R.N.
- Email: bernsted@mail.nih.gov
- Phone: (240) 760-6189
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.