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

Malignant Neoplasm Clinical Trial

Official title:

An Investigation of the Role of Germ-Line Mutations in Cancer Predisposition, Tumor Biology, and Response to Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02280161
• Other study ID #: 14-001115
• Secondary ID: NCI-2014-02065JC
• Status: Recruiting
• Start date: September 16, 2014
• Est. completion date: September 16, 2025

Study information

• Verified date: August 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 16, 2025
• Est. primary completion date: September 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• cytology specimen collection procedure
Correlative studies

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Response to treatment	The impact of inherited variants on response to treatment will be determined.	Up to 5 years
Primary	Cancer development	The role of inherited variants in clinical and pathological cancer development will be determined.	Up to 5 years