Molecular Genetics Studies of Cancer Patients and Their Relatives

Recruiting

• Conditions: Malignant Neoplasm

• Registration Number: NCT04185935
• Lead Sponsor: City of Hope Medical Center

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To identify rare cancer patients and families in whom the pattern of disease suggests a genetic susceptibility to cancer or other etiology suggestive of a carcinogenic exposure and to characterize the underlying predisposition.

II. To determine the contribution of heredity (genotype) and biomarkers to clinical outcome (phenotype, occurrence of new cancers, prognosis and quality of life) in subgroups of cancer patients with and without clinical high-risk features.

OUTLINE:

Patients 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.

Study Timeline

• Study Start: 1997-04-18
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-04
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-25
• Primary Completion: 2033-08-18
• Study Completion: 2033-08-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 999999

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exploratory biomarkers for future studies	Up to 10 years
Cancer risk assessment	Up to 10 years

Trial Locations

Locations (42)

Valleywise Comprehensive Health Center - Phoenix; 🇺🇸 Phoenix, Arizona, United States

John Muir Medical Center-Concord Campus; 🇺🇸 Concord, California, United States

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Saint Jude Medical Center; 🇺🇸 Fullerton, California, United States

Saddleback Memorial Medical Center; 🇺🇸 Laguna Hills, California, United States

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Saint Joseph Hospital - Orange; 🇺🇸 Orange, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville; 🇺🇸 Roseville, California, United States

Cancer Center of Santa Barbara; 🇺🇸 Santa Barbara, California, United States

Lynn Regional Cancer Center - West; 🇺🇸 Boca Raton, Florida, United States

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