Radiation TherapyRADIANTNCT03133286
Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)
An observational study of Radiation Therapy and Cancer, run by DxTerity Diagnostics at 4 sites in United States.
Trial summary
Collect blood samples and associated clinical data prior to, during, 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, Cancer, Cancer of Anus
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Apr 2017to 25 Feb 2020
- 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: Cancer patients diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) tumors being treated with radiation therapy.
Who may be able to join
- Male and female patients age 18 or older
- Have a permanent address in the United States for the duration of the study
- Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer
- Planned radiation therapy to the abdominal/pelvic area as part of clinical care
- Able to provide informed consent
Who cannot join
- 1. Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
21st Century Oncology
Bradenton, Florida, 34202
DxTerity Diagnostics
Compton, California, 90220
21st Century Oncology
Fort Myers, Florida, 33908
21st Century Oncology
Plantation, Florida, 33324
About this study
Collect blood samples and associated clinical data prior to, during, and post radiation treatment.
Read the detailed description
In order to further refine and independently validate the performance of DxTerity's test developed during the previous pilot study, the study will collect pre-, during, and post-irradiation blood samples and associated clinical and self-reported information from up to five hundred (500) subjects for analysis. Patients with a diagnosis of primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer requiring radiation treatment to the primary disease site will be included in the study. Combining chemotherapy is allowed.
Blood samples for this study will be collected from cancer patients scheduled to undergo radiation therapy prior to and either during or after treatment. Approximately 150μL of blood per time point will be obtained via fingerstick remotely, from the participant's home or doctor's office; participation in this study will not affect any aspect of patient treatment. Samples will be collected using DxTerity's proprietary DxCollect® MCD Fingerstick Kit (MCD).
- Conditions
- Radiation Therapy, Cancer, Cancer of Anus, Cancer of Bladder, Cancer of Cervix, Cancer of Colon
- Keywords
- Anal Cancer, Bladder, Cervical, Colorectal, Esophageal, Gallbladder, Liver, Ovarian, Pancreas, Pancreatic, Prostate, Rectal, Renal, Kidney, Stomach, Testicular, Uterine, Cancer, Radiation Therapy, Radiation Treatment
- Medical subject headings
- Neoplasms, Anus Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Esophageal Neoplasms, Gallbladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain pre- and post-irradiation participant-collect blood samples
Obtain pre-irradiation participant-collected blood sample and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start6 Apr 2017
- Primary completion24 Feb 2020
- Study completion25 Feb 2020
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- DxTerity Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133286
- Sponsor's protocol ID
- DXT-RADTOX-AC03
- Other IDs
- HHSN261201600051C
- Acronym
- RADIANT
- Status last verified
- Aug 2024
- First submitted
- 24 Apr 2017
- Last updated
- 7 Aug 2024
- 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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)
- ClinicalTrials.gov ID
- NCT03133286
- Acronym / sponsor ID
- RADIANT / DXT-RADTOX-AC03
- Conditions
- Radiation Therapy, Cancer, Cancer of Anus, Cancer of Bladder, Cancer of Cervix, Cancer of Colon
- Keywords
- Anal Cancer, Bladder, Cervical, Colorectal, Esophageal, Gallbladder, Liver, Ovarian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- DxTerity DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 28 Apr 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, during, and post radiation treatment.
Detailed description
In order to further refine and independently validate the performance of DxTerity's test developed during the previous pilot study, the study will collect pre-, during, and post-irradiation blood samples and associated clinical and self-reported information from up to five hundred (500) subjects for analysis. Patients with a diagnosis of primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer requiring radiation treatment to the primary disease site will be included in the study. Combining chemotherapy is allowed.
Blood samples for this study will be collected from cancer patients scheduled to undergo radiation therapy prior to and either during or after treatment. Approximately 150μL of blood per time point will be obtained via fingerstick remotely, from the participant's home or doctor's office; participation in this study will not affect any aspect of patient treatment. Samples will be collected using DxTerity's proprietary DxCollect® MCD Fingerstick Kit (MCD).
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
- Cancer patients diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) tumors being treated with radiation therapy.
Key inclusion criteria (5 listed)
- Male and female patients age 18 or older
- Have a permanent address in the United States for the duration of the study
- Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer
- Planned radiation therapy to the abdominal/pelvic area as part of clinical care
- Able to provide informed consent
Key exclusion criteria (1 listed)
- 1. Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment
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
Obtain pre- and post-irradiation participant-collect blood samples
Time frame: 1.5 years
Obtain pre-irradiation participant-collected blood sample and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 and Cancer, run by DxTerity Diagnostics at 4 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain pre- and post-irradiation participant-collect blood samples (time frame: 1.5 years). 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 Aug 2024.