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Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer

NCT ID: NCT02280161

Last Updated: 2025-11-10

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

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-16

Study Completion Date

2027-09-16

Brief Summary

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This research trial studies germ-line mutations in blood and saliva samples from patients with cancer. Studying samples of blood and saliva from patients with cancer in the laboratory may help doctors learn more about how inherited genetic mutations can affect cancer predisposition (an inherited increase in the risk of developing cancer), their impact on treatment response, and their role in cancer development.

Detailed Description

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PRIMARY OBJECTIVES:

I. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

II. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

SECONDARY OBJECTIVES:

I. To determine the effect of the identified variants on tumor micro-ribonucleic acid (miRNA), protein and gene expression.

II. To study expression of DNA, ribonucleic acid (RNA) or protein in the blood of cancer patients with and without variants of interest to discover correlations between such levels and the presence of cancer and/or response to therapy in these patients.

OUTLINE:

Patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.

After completion of study, patients are followed up for 5 years.

Conditions

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Malignant Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ancillary-Correlative (germ-line mutation analysis)

Patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.

cytology specimen collection procedure

Intervention Type OTHER

Correlative studies

Interventions

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cytology specimen collection procedure

Correlative studies

Intervention Type OTHER

Other Intervention Names

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cytologic sampling

Eligibility Criteria

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Inclusion Criteria

* Pathologically or clinical confirmed tissue diagnosis of a cancer
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

* Patients will be excluded if their cancer cannot be confirmed
* Refusal to sign the informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Weidhaas

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

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Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Joanne B. Weidhaas

Role: primary

Other Identifiers

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NCI-2014-02065

Identifier Type: REGISTRY

Identifier Source: secondary_id

JCCCID488

Identifier Type: OTHER

Identifier Source: secondary_id

14-001115

Identifier Type: -

Identifier Source: org_study_id