RECRUITING

Genomic Profiling in Cancer Patients

Conditions

Solid Tumors Hematologic Cancers tissue blood salvia buccal swab Genomic Profiling hematologic cancer Clinical Assay Research Assay 12-245

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Genomic Profiling in Cancer Patients

Quick Facts

Study Start:2013-01

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01775072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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. * 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. * 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.	* Unwilling or unable to provide informed consent. * 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. * Exclusion criteria are same as those for Part C outlined above.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.
* 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.
* 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.

* Unwilling or unable to provide informed consent.
* 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.
* Exclusion criteria are same as those for Part C outlined above.

Contacts and Locations

Study Contact

David Solit, MD

CONTACT

646-888-2641

Zsofia Stadler, MD

CONTACT

646-888-4039

Principal Investigator

David Solit, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

St. Vincent (Data Collection Only)

Bridgeport, Connecticut, 06606

United States

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, 06102

United States

Norwalk Hospital

Norwalk, Connecticut, 06850

United States

Baptist Alliance MCI

Miami, Florida, 33143

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

United States

NYC Health & Hospitals /Lincoln Medical Center

Bronx, New York, 10451

United States

New York Cancer & Blood Specialists (Data collection only)

Bronx, New York, 10469

United States

Kings County Hopsital Center

Brooklyn, New York, 11203

United States

Memorial Sloan Kettering Cancer Commack

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432

United States

Metropolitan Hospital Center

New York, New York, 10029

United States

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, 10035

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

United States

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

David Solit, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-01

Study Completion Date2026-01

Study Record Updates

Study Start Date2013-01

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

tissue
blood
salvia
buccal swab
Genomic Profiling
Solid Tumors
hematologic cancer
Clinical Assay
Research Assay
12-245

Additional Relevant MeSH Terms

Solid Tumors
Hematologic Cancers