At a glance
ClinicalIndex Comparison Record- ✓Patients with cancer history or undergoing diagnostic procedure to confirm/exclude cancer diagnosis
- ✓Any participant having a test/procedure with potential to yield bankable specimen
- ✓Participants with archival tissue/blood/bodily fluids not yet approached for research participation
- ✓Part B: Successfully registered to Part A of MSKCC IRB# 12-245
- ✕Unwilling or unable to provide informed consent
- ✕Part C: Solid tumor patients with acute/chronic hematologic neoplasm precluding blood/saliva use for germline DNA
- ✕Part C: Solid tumor patients with prior allogeneic BMT without pre-BMT germline sample
- ✕Part C: Hematologic cancer patients with prior allogeneic BMT without pre-BMT germline sample
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Genomic Profiling in Cancer Patients
In Brief
An observational study evaluating molecular profiling of tumors and Clinical Germline Analysis for Solid Tumors and Hematologic Cancers. Currently recruiting, targeting 200 participants across 18 sites.
Detailed Summary
The purpose of this study is to determine whether certain genes in cancer may be abnormal. When a gene is abnormal this is called a mutation. Most mutations in cancer cells are not inherited (passed down from parents) but happen after birth in the cancer itself. Most cancers have many mutations. Some of these mutations are important for the cancer cells to survive while others are not. The goal of this study is test cancer for certain mutations using leftover tumor tissue from a previous surgery or biopsy. Participants will also be asked to provide a tube of blood cheek (also known as a buccal) swab, or a saliva sample that contains normal genes for comparison. The purpose of Part B of this study is to: Understand how genetic changes in tumor effect the chance of responding to experimental cancer treatment. Understand how the genes in the tumor change overtime in response to targeted cancer treatment.
Study Details
Timeline
Interventions
Part A is the molecular profiling of tumors. No new tumor biopsies will be performed in the context of Part A. If a pt does have a surgery or tumor biopsy , leftover tissue (or an additional core) from this procedure may be used for molecular profiling. Clinical Assay(s): This testing will be performed in the CLIA-certified Molecular Diagnostics Service laboratory. Research Assay(s): This protocol will also be used as a platform to pilot the use of investigational "next-generation" profiling technologies .including whole exome sequencing, whole genome sequencing RNA sequencing cell-free tumor DNA/RNA sequencing, proteomics, \& others. To confirm the findings obtained on these assays using an orthogonal assay, additional sequencing such as Sanger,Sequenom, MiSeq or IMPACT testing may be utilized in either the CLIA or non-CLIA setting Part B: DTC Cohort Pts successfully registered to Part B of this study will be eligible for minimal risk collection \& research biopsies.
Part C: Clinical Germline Analysis Participants who have donated a matched normal peripheral blood sample for comparison to somatic sequence will be offered the opportunity to have that germline DNA sample analyzed for the presence of deleterious or likely deleterious mutations in genes on the MSK-IMPACT panel that are known to be linked to inherited susceptibility or that are included on consensus lists of genes that should undergo secondary analysis (e.g. the "ACMG list"). Part D: Germline Profiling for Individuals at Elevated Cancer Risk