Trials / Active Not Recruiting
Active Not RecruitingNCT02243592
Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 170 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.
Detailed description
PRIMARY OBJECTIVES: I. To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or standard systemic treatments using whole exome and/or targeted deep sequencing, as well as potentially other sequencing and other molecular characterization methods (if adequate tissue exists). II. To explore associations between the identified molecular indicators and the putative mechanism of action of the treatment received by the patient. III. To test the feasibility of identifying "exceptional responders", obtaining the relevant tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep sequencing on these samples. OUTLINE: Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing, promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Undergo sequencing and SNP analysis |
Timeline
- Start date
- 2014-09-24
- Primary completion
- 2021-03-04
- Completion
- 2027-04-30
- First posted
- 2014-09-18
- Last updated
- 2026-04-17
Locations
73 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02243592. Inclusion in this directory is not an endorsement.