Prospective Screening for Patient-Specific Genotypes and Phenotypes That Influence Drug Dosing and Trial Selection in Cancer Patients

NCT02706652 | Terminated

• 2 other identifiers: 16007616-C-0076
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Background: People's genetic markers and other genetic characteristics can affect their response to drug therapy. Researchers want to screen people for these markers and characteristics. They want to do this before the people are screened for studies at the National Cancer Institute. That should save time that can be lost when people go through the whole screening for a study only to find out they cannot join. The data collected may also be used to select the proper dose of anticancer agents that are being studied. Objective: To screen people for genetic markers and/or baseline characteristics. These will be used to determine if they can enroll in a clinical trial. They may also be used to select the proper dose of anticancer agents that are being tested. Eligibility: Adults 18 and older who are being considered for or being treated in a National Cancer Institute study Design: Participants will have their blood drawn for genetic tests. Some participants will have a cheek swab. Participants genetic data will be stored for future research. It could be shared with other researchers.

Conditions

Cancer

Keywords

Screening; Genotype; Drug Dosing; Trial Selection

Outcome Measures

Primary Outcomes (1)

• To provide pharmacogenomic and/or biomarker analysis to support enrollment of patients on clinical trials that require such markers prior to enrollment.

  Collection of 6 mL of peripheral blood to analyzed via DMET Plus kit for pathway genotype of enzymes and transporters with putative relevance for the drug of interest.

  duration of study

Study Arms (1)

all patients

all eligible patients

Eligibility Criteria

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

Study Population

Any patient who is being evaluated for and/or treated on one of the following IRB-approved protocols at the National Cancer Institute: 12-C-0151, or 09-C-0173, or 18-C-0061.

You may qualify if:

• Any patient who is being evaluated for and/or treated on an IRB-approved protocol at the National Cancer Institute.
• Age \>18 years.
• Ability of subject to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• \- A patient will be excluded if there is an insufficient quality or quantity of sample available to perform the assay and no further sample can be drawn in order to re-assess the status of a genetic or biomarker.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms

Study Officials

• William D Figg, Pharm.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 11, 2016
• Study Start: May 22, 2018
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)