Clinical trial NCT04185935: Molecular Genetics Studies of Cancer Patients and Their Relatives
Official title: Molecular Genetics Studies of Cancer Patients and Their Relatives
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-04
Enrollment: 999999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with a family history of cancer

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.

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

Primary outcomes:
measure: Cancer risk assessment
timeFrame: Up to 10 years
measure: Exploratory biomarkers for future studies
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valleywise Comprehensive Health Center - Phoenix
state: Arizona
city: Concord
country: United States
facility: John Muir Medical Center-Concord Campus
state: California
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Fullerton
country: United States
facility: Saint Jude Medical Center
state: California
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: Saint Joseph Hospital - Orange
state: California
city: Roseville
country: United States
facility: Sutter Cancer Centers Radiation Oncology Services-Roseville
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara
state: California
city: Boca Raton
country: United States
facility: Lynn Regional Cancer Center - West
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Chicago
country: United States
facility: John H Stroger Jr Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Cedar Rapids
country: United States
facility: Mercy Hospital
state: Iowa
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Frederick
country: United States
facility: Frederick Oncology Hematology Associates
state: Maryland
city: Brighton
country: United States
facility: Steward Saint Elizabeth's Medical Center
state: Massachusetts
city: Flemington
country: United States
facility: Hunterdon Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Medical Center-Downtown
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants
state: New Mexico
city: Albuquerque
country: United States
facility: Presbyterian Kaseman Hospital
state: New Mexico
city: Mount Kisco
country: United States
facility: Mount Kisco Medical Group at Northern Westchester Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Health Quest Medical Practice PC-Cardio Thoracic
state: New York
city: Canton
country: United States
facility: Aultman Health Foundation
state: Ohio
city: Bend
country: United States
facility: Saint Charles Health System
state: Oregon
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Amarillo
country: United States
facility: The Don and Sybil Harrington Cancer Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
state: Texas
city: Laredo
country: United States
facility: Doctor's Hospital of Laredo
state: Texas
city: Lubbock
country: United States
facility: Covenant Medical Center
state: Texas
city: Fond Du Lac
country: United States
facility: Saint Agnes Hospital/Agnesian Cancer Center
state: Wisconsin
city: Waukesha
country: United States
facility: ProHealth Waukesha Memorial Hospital
state: Wisconsin
city: Cheyenne
country: United States
facility: Cheyenne Regional Medical Center-West
state: Wyoming
city: Bogotá
country: Colombia
facility: Clinica del Country
state: Cundinamarca
city: Medellín
country: Colombia
facility: Instituto de Cancerologia Las Americas
city: Guadalajara
country: Mexico
facility: University of Guadalajara
state: Jalisco
city: Mexico City
country: Mexico
facility: Salvador Zubiran National Institute of Health Sciences and Nutrition
state: Tlalpan
city: Nuevo Leon
country: Mexico
facility: Monterrey Institute of Technology-TecSalud
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: City of Hope Medical Center
name: Stephen Gruber, MD
role: PRINCIPAL_INVESTIGATOR
References: