Recruiting

Observational Study

Sponsor:

DxTerity Diagnostics

Code:

NCT03142425

Conditions

Radiation Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Radiation Therapy

Study ID

NCT03142425

Start date

Jun 19, 2017

Status verified date

Feb, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Collection of blood samples from patients prior to and post irradiation treatment. [ Time Frame: Up to 4 months, from informed consent through follow up activities. ]

Central Contacts and Locations

Central contacts

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Yi-Jen Chen, MD

Kaiser Permanente Los Angeles Medical Group

Recruiting

Los Angeles, California, United States, 90027

Contacts

Principal Investigator:

Michael R. Girvigian, MD

More Information

Sponsor

DxTerity Diagnostics

Last update posted

Feb 7, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DxTerity Diagnostics on 2019-02-07.