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

NCT02280161 | Recruiting

• 3 other identifiers: 14-001115NCI-2014-02065JCCCID488
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (4)

• Prevalence of germ-line variants

  The prevalence of germ-line variants of interest will be compared to the baseline prevalence found using available large human genomic DNA collections. The primary statistical analysis will involve comparisons of genotypes between with (cases) and without (controls) the germ-line mutation. This analysis will include Pearson's chi-square analysis or Fisher's exact test and computation of odds ratios to assess the relationship of the genetic polymorphism and cancer risk.

  Up to 5 years

• Overall genotype frequencies

  The overall genotype frequencies among the cases and expected control levels will first be compared with the frequencies expected from Hardy-Weinberg equilibrium by goodness-of-fit chi-square. Odds ratios and 95% confidence intervals will be used to estimate risk associated with the variant genotypes by using both univariate and unconditional multivariate logistic regression models.

  Up to 5 years

• Response to treatment

  The impact of inherited variants on response to treatment will be determined.

  Up to 5 years

• Cancer development

  The role of inherited variants in clinical and pathological cancer development will be determined.

  Up to 5 years

Study Arms (1)

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.

Other: cytology specimen collection procedure

Interventions

cytology specimen collection procedure OTHER

Correlative studies

Also known as: cytologic sampling

Ancillary-Correlative (germ-line mutation analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with a confirmed diagnosis of cancer.

You may qualify if:

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

You may not qualify if:

• Patients will be excluded if their cancer cannot be confirmed
• Refusal to sign the informed consent

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample of 30mL or a saliva collection (obtained by spitting into a special collection cup) will be obtained from each patient.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Joanne Weidhaas

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: September 16, 2014
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): September 16, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)