Molecular Genetics Studies of Cancer Patients and Their Relatives

NCT ID: NCT04185935

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

999999 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-04-18

Study Completion Date

2033-08-18

Brief Summary

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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

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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.

Conditions

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Malignant Neoplasm

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type OTHER

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

Intervention Type OTHER

Ancillary studies

Interventions

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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

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Gruber, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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Valleywise Comprehensive Health Center - Phoenix

Phoenix, Arizona, United States

Site Status RECRUITING

John Muir Medical Center-Concord Campus

Concord, California, United States

Site Status RECRUITING

City of Hope Medical Center

Duarte, California, United States

Site Status RECRUITING

Saint Jude Medical Center

Fullerton, California, United States

Site Status RECRUITING

Saddleback Memorial Medical Center

Laguna Hills, California, United States

Site Status RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Saint Joseph Hospital - Orange

Orange, California, United States

Site Status RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status RECRUITING

Cancer Center of Santa Barbara

Santa Barbara, California, United States

Site Status RECRUITING

Lynn Regional Cancer Center - West

Boca Raton, Florida, United States

Site Status RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Kootenai Cancer Center

Post Falls, Idaho, United States

Site Status RECRUITING

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Suburban Hospital

Bethesda, Maryland, United States

Site Status RECRUITING

Frederick Oncology Hematology Associates

Frederick, Maryland, United States

Site Status RECRUITING

Steward Saint Elizabeth's Medical Center

Brighton, Massachusetts, United States

Site Status RECRUITING

Hunterdon Medical Center

Flemington, New Jersey, United States

Site Status RECRUITING

Lovelace Medical Center-Downtown

Albuquerque, New Mexico, United States

Site Status RECRUITING

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Site Status RECRUITING

Presbyterian Kaseman Hospital

Albuquerque, New Mexico, United States

Site Status RECRUITING

Mount Kisco Medical Group at Northern Westchester Hospital

Mount Kisco, New York, United States

Site Status RECRUITING

Health Quest Medical Practice PC-Cardio Thoracic

Poughkeepsie, New York, United States

Site Status RECRUITING

Aultman Health Foundation

Canton, Ohio, United States

Site Status RECRUITING

Saint Charles Health System

Bend, Oregon, United States

Site Status RECRUITING

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Site Status RECRUITING

Reading Hospital

West Reading, Pennsylvania, United States

Site Status RECRUITING

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

Site Status RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Doctor's Hospital of Laredo

Laredo, Texas, United States

Site Status RECRUITING

Covenant Medical Center

Lubbock, Texas, United States

Site Status RECRUITING

Saint Agnes Hospital/Agnesian Cancer Center

Fond du Lac, Wisconsin, United States

Site Status RECRUITING

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status RECRUITING

Cheyenne Regional Medical Center-West

Cheyenne, Wyoming, United States

Site Status RECRUITING

Clinica del Country

Bogotá, Cundinamarca, Colombia

Site Status RECRUITING

Instituto de Cancerologia Las Americas

Medellín, , Colombia

Site Status RECRUITING

University of Guadalajara

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Salvador Zubiran National Institute of Health Sciences and Nutrition

Mexico City, Tlalpan, Mexico

Site Status RECRUITING

Monterrey Institute of Technology-TecSalud

Nuevo León, , Mexico

Site Status RECRUITING

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Site Status RECRUITING

University of Puerto Rico

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

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United States Colombia Mexico Peru Puerto Rico

Central Contacts

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Stephen Gruber

Role: CONTACT

Facility Contacts

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Ian K. Komenaka

Role: primary

602-344-5368

Shellie Campos

Role: primary

925-947-3322

Jeffrey N. Weitzel

Role: primary

626-218-4334

William E. Lawler

Role: primary

714-446-5801

Jeffrey N. Weitzel

Role: primary

626-218-4334

Charite Ricker

Role: primary

323-409-7710

Jeffrey N. Weitzel

Role: primary

626-218-4334

Kristie A. Bobolis

Role: primary

916-782-5106

Frederic C. Kass

Role: primary

805-563-5854

Louise E. Morrell

Role: primary

561-955-2141

Zdenka E. Segota

Role: primary

954-267-7709

Jeffrey W. Allen

Role: primary

208-625-4728

Pamela Ganschow

Role: primary

312-864-4436

Lydia Usha

Role: primary

312-563-2200

Amie Hass

Role: primary

319-398-6732

Carolyn B. Hendricks

Role: primary

301-897-1503

Patricia A. Rice

Role: primary

301-418-5010

Beth B. Herrick

Role: primary

617-789-3232

Kenneth B. Blankstein

Role: primary

908-788-2566

Malcolm H. Purdy

Role: primary

505-727-3040

Annette C. Fontaine

Role: primary

505-480-1462

Kenneth J. Smith

Role: primary

505-559-6143

Nancy Cohen

Role: primary

914-242-7649

Jonathan Clyman

Role: primary

845-483-6279

Shruti Trehan

Role: primary

330-363-2286

Coralia B. Calomeni

Role: primary

541-706-5800

Michael B. Dabrow

Role: primary

Terrence P. Cescon

Role: primary

484-628-8000

Anita Ravipati

Role: primary

April D. Sorrell

Role: primary

713-798-6970

Gary W. Unzeitig

Role: primary

956-726-3691

Isaac Tafur

Role: primary

806-725-7993

Michael W. Jones

Role: primary

920-926-4100

Christopher R. Hake

Role: primary

262-928-5539

Jennifer Van Horn

Role: primary

307-996-1517

Sandra X. Franco

Role: primary

011 57 1 5300470

Alicia M. Cock-Rada

Role: primary

574 3409393

Adrian Daneri-Navarro

Role: primary

33 10585261 ext. 33871

Yanin Chavarri

Role: primary

525554870900 ext. 2254

Cynthia Villarreal-Garza

Role: primary

528183898395

Julio E. Abugattas Saba

Role: primary

51993579810

Marcia R. Cruz-Correa

Role: primary

787-772-8300

Other Identifiers

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NCI-2019-05695

Identifier Type: REGISTRY

Identifier Source: secondary_id

96144

Identifier Type: OTHER

Identifier Source: secondary_id

96144

Identifier Type: -

Identifier Source: org_study_id

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