Molecular Genetics Studies of Cancer Patients and Their Relatives

Overview

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.

Interventions

• Other Biospecimen Collection
  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 Questionnaire Administration
  Ancillary studies

Primary outcome measures

• Cancer risk assessment [Time frame: Up to 10 years]
• Exploratory biomarkers for future studies [Time frame: Up to 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Family-based

Study locations

United States · 35 centers

• Valleywise Comprehensive Health Center - Phoenix — Phoenix
• John Muir Medical Center-Concord Campus — Concord
• City of Hope Medical Center — Duarte
• Saint Jude Medical Center — Fullerton
• Saddleback Memorial Medical Center — Laguna Hills
• USC / Norris Comprehensive Cancer Center — Los Angeles
• Saint Joseph Hospital - Orange — Orange
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville
• … and 27 more centers

Mexico · 3 centers

• University of Guadalajara — Guadalajara
• Salvador Zubiran National Institute of Health Sciences and Nutrition — Mexico City
• Monterrey Institute of Technology-TecSalud — Nuevo León

Colombia · 2 centers

• Clinica del Country — Bogotá
• Instituto de Cancerologia Las Americas — Medellín

Peru · 1 center

• Instituto Nacional de Enfermedades Neoplasicas — Lima

Puerto Rico · 1 center

• University of Puerto Rico — San Juan

Identifiers

NCT: NCT04185935 · 96144 · NCI-2019-05695 · 96144

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗