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Recruiting NCT02280161

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

— Observational Malignant Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cytology specimen collection procedure.
Who it may be relevant to
Registry conditions: Malignant Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Other cytology specimen collection procedure
    Correlative studies

Primary outcome measures

  • Prevalence of germ-line variants [Time frame: Up to 5 years]
  • Overall genotype frequencies [Time frame: Up to 5 years]
  • Response to treatment [Time frame: Up to 5 years]
  • Cancer development [Time frame: Up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Jonsson Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT02280161 · 14-001115 · NCI-2014-02065 · JCCCID488

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗