Radiation TherapyNCT03142425
Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy
An observational study of Radiation Therapy, run by DxTerity Diagnostics at 2 sites in United States.
Trial summary
Collect blood samples and associated clinical data prior to and post radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Therapy
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jun 2017to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients, age 18 or older, diagnosed with a primary rectal or esophageal/gastroesophageal junction cancer undergoing radiation therapy.
Who may be able to join
- Male and female patients age 18 or older
- Diagnosed with a primary rectal or esophageal cancer
- 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
- Combining chemotherapy is allowed
- ECOG Performance Status 0-2
- Able to provide written informed consent
Who cannot join
- Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent
- Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Bianca Del Vecchio, 626-256-4673 ext. 64402, bdelvecchio@coh.org
Yi-Jen Chen, MD
- Recruiting
Kaiser Permanente Los Angeles Medical Group
Los Angeles, California, 90027
Sandra Baker-Bolden, 323-783-5532, sandra.t.baker@kp.org
Jennifer Keyte, 323-783-5071, jennifer.n.keyte@kp.org
About this study
Collect blood samples and associated clinical data prior to and post radiation treatment.
Read the detailed description
Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.
- Conditions
- Radiation Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of blood samples from patients prior to and post irradiation treatment.
Explore and validate a radiation sensitivity test for determining radiation treatment tumor response by refining and analyzing gene expression signature of blood samples collected from 150 patients prior to and post irradiation treatment.
Measured: Up to 4 months, from informed consent through follow up activities.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start19 Jun 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DxTerity Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Terbrueggen, PhD, Study director, President and CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142425
- Sponsor's protocol ID
- DXT-RADTOX-AC02
- Other IDs
- 261201600051C-0-0-1
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2017
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT03142425
- Acronym / sponsor ID
- DXT-RADTOX-AC02
- Conditions
- Radiation Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- DxTerity DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collect blood samples and associated clinical data prior to and post radiation treatment.
Detailed description
Exploratory study to collect paired pre- and post-irradiation blood samples from 150 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients, age 18 or older, diagnosed with a primary rectal or esophageal/gastroesophageal junction cancer undergoing radiation therapy.
Key inclusion criteria (6 listed)
- Male and female patients age 18 or older
- Diagnosed with a primary rectal or esophageal cancer
- 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
- Combining chemotherapy is allowed
- ECOG Performance Status 0-2
Key exclusion criteria (2 listed)
- Subjects who have received radiation within three (3) months to esophagogastric or pelvic areas prior to consent
- Subjects, who in the opinion of the investigator, may not be able to comply with the requirements of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Explore and validate a radiation sensitivity test for determining radiation treatment tumor response by refining and analyzing gene expression signature of blood samples collected from 150 patients prior to and post irradiation treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Radiation Therapy
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Active, not recruitingPhase 2
Single Fraction or Multi-fraction Palliative Radiation Therapy for the Improvement of Quality of Life in Patients With Metastatic Gynecologic Cancers
Metastatic Malignant Female Reproductive System Neoplasm
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Terbrueggen, PhD study director
President and CEO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Therapy, run by DxTerity Diagnostics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Arruda, B.S. (310-537-7857, aarruda@dxterity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.