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

Jonsson Comprehensive Cancer Center logo

Jonsson Comprehensive Cancer Center

Status

Enrolling

Conditions

Malignant Neoplasm

Treatments

Other: cytology specimen collection procedure

Study type

Observational

Funder types

Other

Identifiers

NCT02280161
NCI-2014-02065 (Registry Identifier)
JCCCID488 (Other Identifier)
14-001115

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

2,000 participants in 1 patient group

Ancillary-Correlative (germ-line mutation analysis)
Description:
Patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.
Treatment:
Other: cytology specimen collection procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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