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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-C-0076

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Pregnant Women;
Neonates;
Fetuses;
Children

Keywords

Screening;
Genotype;
Drug Dosing;
Trial Selection

Recruitment Keyword(s)

None

Condition(s)

Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

- 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.

EXCLUSION CRITERIA:

- 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

William D. Figg, Pharm.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 5A01
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6179
figgw@mail.nih.gov

Paula A. Carter, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4B11
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3191
pcartera@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT02706652

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