Molecular Genetics Studies of Cancer Patients and Their Relatives

June 23, 2025 updated by: City of Hope Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

999999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
      • Medellín, Colombia
        • Recruiting
        • Instituto de Cancerologia Las Americas
        • Contact:
        • Principal Investigator:
          • Alicia M. Cock-Rada
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Recruiting
        • Clínica del Country
        • Contact:
        • Principal Investigator:
          • Sandra X. Franco
  • Mexico
      • Nuevo Leon, Mexico
        • Recruiting
        • Monterrey Institute of Technology-TecSalud
        • Contact:
        • Principal Investigator:
          • Cynthia Villarreal-Garza
    • Jalisco
      • Guadalajara, Jalisco, Mexico, CP 44340
        • Recruiting
        • University of Guadalajara
        • Contact:
        • Principal Investigator:
          • Adrian Daneri-Navarro
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Recruiting
        • Salvador Zubiran National Institute of Health Sciences and Nutrition
        • Contact:
        • Principal Investigator:
          • Yanin Chavarri
  • Peru
      • Lima, Peru, Lima 34
        • Recruiting
        • Instituto Nacional de Enfermedades Neoplasicas
        • Contact:
        • Principal Investigator:
          • Julio E. Abugattas Saba
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • Recruiting
        • University of Puerto Rico
        • Contact:
        • Principal Investigator:
          • Marcia R. Cruz-Correa
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Recruiting
        • Valleywise Comprehensive Health Center - Phoenix
        • Contact:
        • Principal Investigator:
          • Ian K. Komenaka
    • California
      • Concord, California, United States, 94520
        • Recruiting
        • John Muir Medical Center-Concord Campus
        • Contact:
        • Principal Investigator:
          • Shellie Campos
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey N. Weitzel
      • Fullerton, California, United States, 92835
        • Recruiting
        • Saint Jude Medical Center
        • Contact:
        • Principal Investigator:
          • William E. Lawler
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • Saddleback Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey N. Weitzel
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Charite Ricker
      • Orange, California, United States, 92868
        • Recruiting
        • Saint Joseph Hospital - Orange
        • Contact:
        • Principal Investigator:
          • Jeffrey N. Weitzel
      • Roseville, California, United States, 95661
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
        • Contact:
        • Principal Investigator:
          • Kristie A. Bobolis
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Cancer Center of Santa Barbara
        • Contact:
        • Principal Investigator:
          • Frederic C. Kass
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Recruiting
        • Lynn Regional Cancer Center - West
        • Contact:
        • Principal Investigator:
          • Louise E. Morrell
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Hospital
        • Contact:
        • Principal Investigator:
          • Zdenka E. Segota
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Cancer Center
        • Contact:
        • Principal Investigator:
          • Jeffrey W. Allen
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Lydia Usha
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • John H Stroger Jr Hospital of Cook County
        • Contact:
        • Principal Investigator:
          • Pamela Ganschow
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Amie Hass
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • Suburban Hospital
        • Contact:
        • Principal Investigator:
          • Carolyn B. Hendricks
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • Frederick Oncology Hematology Associates
        • Contact:
          • Patricia A. Rice
          • Phone Number: 301-418-5010
          • Email: price@fmh.org
        • Principal Investigator:
          • Patricia A. Rice
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Recruiting
        • Steward Saint Elizabeth's Medical Center
        • Contact:
        • Principal Investigator:
          • Beth B. Herrick
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Recruiting
        • Hunterdon Medical Center
        • Contact:
        • Principal Investigator:
          • Kenneth B. Blankstein
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Presbyterian Kaseman Hospital
        • Contact:
          • Kenneth J. Smith
          • Phone Number: 505-559-6143
        • Principal Investigator:
          • Kenneth J. Smith
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Lovelace Medical Center-Downtown
        • Contact:
        • Principal Investigator:
          • Malcolm H. Purdy
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • New Mexico Oncology Hematology Consultants
        • Contact:
        • Principal Investigator:
          • Annette C. Fontaine
    • New York
      • Mount Kisco, New York, United States, 10549-3417
        • Recruiting
        • Mount Kisco Medical Group at Northern Westchester Hospital
        • Contact:
        • Principal Investigator:
          • Nancy Cohen
      • Poughkeepsie, New York, United States, 12601
        • Recruiting
        • Health Quest Medical Practice PC-Cardio Thoracic
        • Contact:
        • Principal Investigator:
          • Jonathan Clyman
    • Ohio
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Health Foundation
        • Contact:
        • Principal Investigator:
          • Shruti Trehan
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Contact:
        • Principal Investigator:
          • Coralia B. Calomeni
    • Pennsylvania
      • Paoli, Pennsylvania, United States, 19301
        • Recruiting
        • Paoli Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Michael B. Dabrow
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Contact:
        • Principal Investigator:
          • Terrence P. Cescon
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • The Don and Sybil Harrington Cancer Center
        • Contact:
        • Principal Investigator:
          • Anita Ravipati
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • April D. Sorrell
          • Phone Number: 713-798-6970
        • Principal Investigator:
          • April D. Sorrell
      • Laredo, Texas, United States, 78041
        • Recruiting
        • Doctor's Hospital of Laredo
        • Contact:
        • Principal Investigator:
          • Gary W. Unzeitig
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • Covenant Medical Center
        • Contact:
        • Principal Investigator:
          • Isaac Tafur
    • Wisconsin
      • Fond Du Lac, Wisconsin, United States, 54935
        • Recruiting
        • Saint Agnes Hospital/Agnesian Cancer Center
        • Contact:
          • Michael W. Jones
          • Phone Number: 920-926-4100
        • Principal Investigator:
          • Michael W. Jones
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Waukesha Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Christopher R. Hake
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Recruiting
        • Cheyenne Regional Medical Center-West
        • Contact:
        • Principal Investigator:
          • Jennifer Van Horn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants with a family history of cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: Questionnaire Administration
Ancillary studies
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cancer risk assessment
Time Frame: Up to 10 years
Up to 10 years
Exploratory biomarkers for future studies
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Stephen Gruber, MD, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 1997

Primary Completion (Estimated)

August 18, 2033

Study Completion (Estimated)

August 18, 2033

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96144 (Other Identifier: City of Hope Comprehensive Cancer Center)
  • NCI-2019-05695 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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