Molecular Genetics Studies of Cancer Patients and Their Relatives

NCT04185935 | Recruiting DMC

• 2 other identifiers: 96144NCI-2019-05695
• Study Type: observational
• Target: 999,999
• Locations: 5 countries
• Sites: 42

Brief Summary

This trial studies the genetic and behavioral factors that may contribute to the development of specific cancers and how these factors may affect the outcome of the disease in patients with a history of cancer and their relatives.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Cancer risk assessment

  Up to 10 years

• Exploratory biomarkers for future studies

  Up to 10 years

Study Arms (1)

Ancillary-correlative (biospecimen collection)

Participants may provide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue.

Other: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Biospecimen Collection OTHER

Provide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue

Ancillary-correlative (biospecimen collection)

Questionnaire Administration OTHER

Ancillary studies

Ancillary-correlative (biospecimen collection)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with a family history of cancer

You may qualify if:

• Individuals must have a personal history of cancer and/or a family history of cancer suggestive of the presence of an inherited predisposition. This inherited predisposition might manifest as:
• Young age cancer diagnosis
• Multiple primary neoplasms in affected member
• The presence of rare tumor types in the family
• Congenital malformations
• Any other family clustering of cancer
• Any other cancer-predisposing genetic diseases/conditions
• Individuals may also be eligible by participation in the City of Hope Cancer Screening \& Prevention Program Network (CSPPN) clinical service or on the basis of membership in a group known or suspected to have an increased risk of carrying a genetic alteration or of sustaining a particular exposure that would place that at increased risk of cancer. (Examples would include members of occupational cohorts like asbestos workers, individuals with multiple dysplastic nevi in the absence of a family history of cancer, and individuals descended from a particular tribe in the American Southwest who have an increased incidence of a rare genetic alteration associated with an increased risk of a specific cancer.)
• Individuals and families may be referred to us in a number of different ways. After initial contact is made with a individual or family by family studies personnel; an individual within the bloodline will be identified as the historian. There may be more than one historian within a family
• At least one historian must be wiling to provide information or access as needed to contact appropriate family members for documentation of cancer and for consent. An individual is considered to be eligible to participate if they criteria; contact with relatives is not always indicated
• Individuals who are under 18 are eligible for study if they meet the criteria. Consent for participation must be given by a legal guardian or parent
• Deceased patients may be included in the study. Public records, such as death certificates, can be used to confirm information from individuals or family members. If medical records are needed, consent for these records will be obtained from the deceased's next of kin. Next of kin refers to the following hierarchy of relatives; spouse, offspring, parents, and siblings. (Any further use of next of kin in this protocol should relate back to this hierarchy.) Archived tissue samples, such as pathology blocks or snap frozen tumor from a pathology department tumor bank (discard specimens) may be used for genetic research

You may not qualify if:

• A family may be ineligible for study if the historian will not allow access to anyone within the family and thus, the accuracy of the family history cannot be established

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (42)

Valleywise Comprehensive Health Center - Phoenix

Phoenix, Arizona, 85008, United States

RECRUITING

John Muir Medical Center-Concord Campus

Concord, California, 94520, United States

RECRUITING

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Saint Jude Medical Center

Fullerton, California, 92835, United States

RECRUITING

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Saint Joseph Hospital - Orange

Orange, California, 92868, United States

RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

RECRUITING

Cancer Center of Santa Barbara

Santa Barbara, California, 93105, United States

RECRUITING

Lynn Regional Cancer Center - West

Boca Raton, Florida, 33428, United States

RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Kootenai Cancer Center

Post Falls, Idaho, 83854, United States

RECRUITING

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Suburban Hospital

Bethesda, Maryland, 20814, United States

RECRUITING

Frederick Oncology Hematology Associates

Frederick, Maryland, 21702, United States

RECRUITING

Steward Saint Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

RECRUITING

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

RECRUITING

Lovelace Medical Center-Downtown

Albuquerque, New Mexico, 87102, United States

RECRUITING

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, 87109, United States

RECRUITING

Presbyterian Kaseman Hospital

Albuquerque, New Mexico, 87110, United States

RECRUITING

Mount Kisco Medical Group at Northern Westchester Hospital

Mount Kisco, New York, 10549-3417, United States

RECRUITING

Health Quest Medical Practice PC-Cardio Thoracic

Poughkeepsie, New York, 12601, United States

RECRUITING

Aultman Health Foundation

Canton, Ohio, 44710, United States

RECRUITING

Saint Charles Health System

Bend, Oregon, 97701, United States

RECRUITING

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

RECRUITING

Reading Hospital

West Reading, Pennsylvania, 19611, United States

RECRUITING

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Doctor's Hospital of Laredo

Laredo, Texas, 78041, United States

RECRUITING

Covenant Medical Center

Lubbock, Texas, 79410, United States

RECRUITING

Saint Agnes Hospital/Agnesian Cancer Center

Fond du Lac, Wisconsin, 54935, United States

RECRUITING

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

RECRUITING

Cheyenne Regional Medical Center-West

Cheyenne, Wyoming, 82001, United States

RECRUITING

Clinica del Country

Bogotá, Cundinamarca, Colombia

RECRUITING

Instituto de Cancerologia Las Americas

Medellín, Colombia

RECRUITING

University of Guadalajara

Guadalajara, Jalisco, CP 44340, Mexico

RECRUITING

Salvador Zubiran National Institute of Health Sciences and Nutrition

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Monterrey Institute of Technology-TecSalud

Nuevo León, Mexico

RECRUITING

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

RECRUITING

University of Puerto Rico

San Juan, 00936, Puerto Rico

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, eyebrow pluck, urine, tissue

MeSH Terms

Conditions

Neoplasms

Study Officials

• Stephen Gruber, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Gruber

CONTACT

sgruber@coh.org

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 4, 2019
• Study Start: April 18, 1997
• Primary Completion (Estimated): August 18, 2033
• Study Completion (Estimated): August 18, 2033
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

PR (1); PE (1); ME (3); US (35); CO (2)