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NCT01775072 | RECRUITING | Solid Tumors

Genomic Profiling in Cancer Patients
Sponsor:

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Solid Tumors

Hematologic Cancers

Intervention/treatment

molecular profiling of tumors

Clinical Germline Analysis

Study Type : OBSERVATIONAL
Estimated Enrollment : 200 participants
Official Title : Genomic Profiling in Cancer Patients
Actual Study Start Date : 2013-01
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2026-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Part A
    • * Patients with a history of cancer or patients without a documented cancer history undergoing a surgical procedure, endoscopy, biopsy, or liquid biopsy (for example cell free DNA testing) to confirm or exclude a cancer diagnosis, or
    • * Any participant having a test or procedure that has the potential to provide a specimen that can be banked for future research purposes, or
    • * Any participant who has already had a diagnostic or therapeutic procedure that has yielded tissue, blood or other bodily fluids presently in the archive but who has not yet been approached to participate is also eligible.
    • Part B
      • * Patients must be successfully registered to Part A of MSKCC IRB# 12-245
      • * Prior written approval for patient consent obtained from the Principal/Co-Principal Investigator of MSKCC IRB # 12-245.
      • Part C
        • * Patient must be receiving ongoing care at MSK or a CHERPn/ Alliance/Affiliate site or have previously consulted with an MSK physician.
        • * Patient must have successfully consented to Part A of this study.
        • Part D
          • * Patients with no personal cancer history at increased risk for cancer development due to family history, molecular cancer marker, know carrier status of a gene associated with increased cancer risk or prior/ongoing environmental exposures or lifestyle factors.
          Exclusion Criteria
          • All Parts
            • * Unwilling or unable to provide informed consent.
            • Part C
              • * All patients consenting to Part A are eligible to consent to 12-245, Part C. Most patients will be eligible to receive clinical germline testing with return of results to the patient/health care providers. However, several exclusion criteria apply and are outlined below
              • 1. Solid tumor patients: Secondary germline analysis using BAM files generated for MSK-IMPACT testing is not an option for patients with solid tumors and an acute or chronic hematologic neoplasm that would preclude the use of blood or saliva as a source of germline DNA. Such patient may be eligible for primary germline testing using a non-blood source of germline DNA as per standard clinical guidelines. Solid tumor patients who have had an allogenic bone marrow/stem cell transplant will only be considered eligible for germline testing under Part C if a sample adequate for germline testing had previously been collected prior to allogenic bone marrow/stem cell transplant.
              • 2. Hematologic cancer patients: For patients with a hematopoietic neoplasm, germline testing may be an option under Part C using nail clippings or another non-blood source of DNA as per standard clinical practice. For patients who have had an allogenic bone marrow/stem cell transplant, clinical germline testing will only be considered under Part C if a sample adequate for germline testing had previously been collected prior to Allogenic bone marrow/stem cell transplant.
              • Part D
              • * Exclusion criteria are same as those for Part C outlined above.
Genomic Profiling in Cancer Patients

Location Details

NCT01775072

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Connecticut

St. Vincent (Data Collection Only)

Bridgeport, Connecticut, United States, 06606

NOT YET RECRUITING

United States, Connecticut

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States, 06102

RECRUITING

United States, Connecticut

Norwalk Hospital

Norwalk, Connecticut, United States, 06850

RECRUITING

United States, Florida

Baptist Alliance MCI

Miami, Florida, United States, 33143

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Kings County Hopsital Center

Brooklyn, New York, United States, 11203

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Commack

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Queens Cancer Center of Queens Hospital

Jamaica, New York, United States, 11432

RECRUITING

United States, New York

Metropolitan Hospital Center

New York, New York, United States, 10029

RECRUITING

United States, New York

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States, 10035

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Medisys Health Network (Data Collection Only)

Richmond Hill, New York, United States, 11418

RECRUITING

United States, New York

NYC Health & Hospitals /Lincoln Medical Center

The Bronx, New York, United States, 10451

RECRUITING

United States, New York

New York Cancer & Blood Specialists (Data collection only)

The Bronx, New York, United States, 10469

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

RECRUITING

United States, Pennsylvania

Lehigh Valley Health Network

Allentown, Pennsylvania, United States, 18103