Molecular Genetics Studies of Cancer Patients and Their Relatives

Sponsor

City of Hope Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04185935

Collaborator

National Cancer Institute (NCI) (NIH)

999,999

Enrollment

Locations

396.6

Anticipated Duration (Months)

23809.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Neoplasm	Other: Biospecimen Collection Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

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.
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 Design

Study Type:

Observational

Anticipated Enrollment :

999999 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

Official Title:

Molecular Genetics Studies of Cancer Patients and Their Relatives

Actual Study Start Date :

Apr 18, 1997

Anticipated Primary Completion Date :

May 5, 2030

Anticipated Study Completion Date :

May 5, 2030

Arms and Interventions

Arm	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: 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

Arm

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: 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

Outcome Measures

Primary Outcome Measures

Cancer risk assessment [Up to 10 years]
Exploratory biomarkers for future studies [Up to 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valleywise Comprehensive Health Center - Phoenix	Phoenix	Arizona	United States	85008
2	John Muir Medical Center-Concord Campus	Concord	California	United States	94520
3	City of Hope Medical Center	Duarte	California	United States	91010
4	Saint Jude Medical Center	Fullerton	California	United States	92835
5	Saddleback Memorial Medical Center	Laguna Hills	California	United States	92653
6	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
7	Saint Joseph Hospital - Orange	Orange	California	United States	92868
8	Sutter Cancer Centers Radiation Oncology Services-Roseville	Roseville	California	United States	95661
9	Cancer Center of Santa Barbara	Santa Barbara	California	United States	93105
10	Lynn Regional Cancer Center - West	Boca Raton	Florida	United States	33428
11	Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
12	Kootenai Cancer Center	Post Falls	Idaho	United States	83854
13	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612
14	Rush University Medical Center	Chicago	Illinois	United States	60612
15	Mercy Hospital	Cedar Rapids	Iowa	United States	52403
16	Suburban Hospital	Bethesda	Maryland	United States	20814
17	Frederick Oncology Hematology Associates	Frederick	Maryland	United States	21702
18	Steward Saint Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135
19	Hunterdon Medical Center	Flemington	New Jersey	United States	08822
20	Lovelace Medical Center-Downtown	Albuquerque	New Mexico	United States	87102
21	New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico	United States	87109
22	Presbyterian Kaseman Hospital	Albuquerque	New Mexico	United States	87110
23	Mount Kisco Medical Group at Northern Westchester Hospital	Mount Kisco	New York	United States	10549-3417
24	Health Quest Medical Practice PC-Cardio Thoracic	Poughkeepsie	New York	United States	12601
25	Aultman Health Foundation	Canton	Ohio	United States	44710
26	Saint Charles Health System	Bend	Oregon	United States	97701
27	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301
28	Reading Hospital	West Reading	Pennsylvania	United States	19611
29	The Don and Sybil Harrington Cancer Center	Amarillo	Texas	United States	79106
30	Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas	United States	77030
31	Doctor's Hospital of Laredo	Laredo	Texas	United States	78041
32	Covenant Medical Center	Lubbock	Texas	United States	79410
33	Saint Agnes Hospital/Agnesian Cancer Center	Fond Du Lac	Wisconsin	United States	54935
34	ProHealth Waukesha Memorial Hospital	Waukesha	Wisconsin	United States	53188
35	Cheyenne Regional Medical Center-West	Cheyenne	Wyoming	United States	82001
36	Clinica del Country	Bogotá	Cundinamarca	Colombia
37	Instituto de Cancerologia Las Americas	Medellín		Colombia
38	University of Guadalajara	Guadalajara	Jalisco	Mexico	CP 44340
39	Salvador Zubiran National Institute of Health Sciences and Nutrition	Mexico City	Tlalpan	Mexico	14080
40	Monterrey Institute of Technology-TecSalud	Nuevo Leon		Mexico
41	Instituto Nacional de Enfermedades Neoplasicas	Lima		Peru	Lima 34
42	University of Puerto Rico	San Juan		Puerto Rico	00936

Sponsors and Collaborators

City of Hope Medical Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Jeffrey N Weitzel, City of Hope Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

City of Hope Medical Center

ClinicalTrials.gov Identifier:

NCT04185935

Other Study ID Numbers:

96144
NCI-2019-05695
96144

First Posted:

Dec 4, 2019

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Sep 16, 2021