Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy

NCT ID: NCT03142425

Last Updated: 2019-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-19

Study Completion Date

2019-12-31

Brief Summary

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Collect blood samples and associated clinical data prior to and post radiation treatment.

Detailed Description

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Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.

Conditions

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Radiation Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients age 18 or older
2. Diagnosed with a primary rectal or esophageal cancer
3. Planned radiation therapy to the esophagogastric area to a minimum of 4140 cGy for esophageal/gastroesophageal junction cancer or to pelvis to a minimum of 4500 cGy for rectal cancer as part of clinical care
4. Combining chemotherapy is allowed
5. ECOG Performance Status 0-2
6. Able to provide written informed consent

Exclusion Criteria

1. Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent
2. Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

DxTerity Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Terbrueggen, PhD

Role: STUDY_DIRECTOR

President and CEO

Locations

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City of Hope

Duarte, California, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Group

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrea Arruda, B.S.

Role: CONTACT

310-537-7857

Kristen Warren, B.S.

Role: CONTACT

310-537-7857

Facility Contacts

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Bianca Del Vecchio

Role: primary

626-256-4673 ext. 64402

Sandra Baker-Bolden

Role: primary

323-783-5532

Jennifer Keyte

Role: backup

323-783-5071

Other Identifiers

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261201600051C-0-0-1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DXT-RADTOX-AC02

Identifier Type: -

Identifier Source: org_study_id

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