Molecular Genetics Studies of Cancer Patients and Their Relatives

Malignant Neoplasm Clinical Trial

Official title:

Molecular Genetics Studies of Cancer Patients and Their Relatives

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185935
• Other study ID #: 96144
• Secondary ID: NCI-2019-0569596
• Status: Recruiting
• Start date: April 18, 1997
• Est. completion date: May 5, 2030

Study information

• Verified date: September 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 999999
• Est. completion date: May 5, 2030
• Est. primary completion date: May 5, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

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
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
Colombia	Clinica del Country	Bogotá	Cundinamarca
Colombia	Instituto de Cancerologia Las Americas	Medellín
Mexico	University of Guadalajara	Guadalajara	Jalisco
Mexico	Salvador Zubiran National Institute of Health Sciences and Nutrition	Mexico City	Tlalpan
Mexico	Monterrey Institute of Technology-TecSalud	Nuevo Leon
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Puerto Rico	University of Puerto Rico	San Juan
United States	Lovelace Medical Center-Downtown	Albuquerque	New Mexico
United States	New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico
United States	Presbyterian Kaseman Hospital	Albuquerque	New Mexico
United States	The Don and Sybil Harrington Cancer Center	Amarillo	Texas
United States	Saint Charles Health System	Bend	Oregon
United States	Suburban Hospital	Bethesda	Maryland
United States	Lynn Regional Cancer Center - West	Boca Raton	Florida
United States	Steward Saint Elizabeth's Medical Center	Brighton	Massachusetts
United States	Aultman Health Foundation	Canton	Ohio
United States	Mercy Hospital	Cedar Rapids	Iowa
United States	Cheyenne Regional Medical Center-West	Cheyenne	Wyoming
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	John Muir Medical Center-Concord Campus	Concord	California
United States	City of Hope Medical Center	Duarte	California
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	Saint Agnes Hospital/Agnesian Cancer Center	Fond Du Lac	Wisconsin
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Frederick Oncology Hematology Associates	Frederick	Maryland
United States	Saint Jude Medical Center	Fullerton	California
United States	Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	Covenant Medical Center	Lubbock	Texas
United States	Mount Kisco Medical Group at Northern Westchester Hospital	Mount Kisco	New York
United States	Saint Joseph Hospital - Orange	Orange	California
United States	Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Valleywise Comprehensive Health Center - Phoenix	Phoenix	Arizona
United States	Kootenai Cancer Center	Post Falls	Idaho
United States	Health Quest Medical Practice PC-Cardio Thoracic	Poughkeepsie	New York
United States	Sutter Cancer Centers Radiation Oncology Services-Roseville	Roseville	California
United States	Cancer Center of Santa Barbara	Santa Barbara	California
United States	ProHealth Waukesha Memorial Hospital	Waukesha	Wisconsin
United States	Reading Hospital	West Reading	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Colombia,  Mexico,  Peru,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer risk assessment		Up to 10 years
Primary	Exploratory biomarkers for future studies		Up to 10 years