- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03133286
Radiotherapy Assessments During Intervention ANd Treatment (RADIANT) (RADIANT)
Study Overview
Status
Conditions
- Cancer
- Cancer of Liver
- Cancer of Pancreas
- Cancer of Stomach
- Cancer of Cervix
- Cancer of Colon
- Cancer of Rectum
- Cancer of Kidney and Renal Pelvis
- Cancer of Prostate
- Radiation Therapy
- Cancer of Esophagus
- Cancer of Ovary
- Cancer of Kidney
- Cancer of Bladder
- Cancer of Gallbladder
- Cancer of Anus
- Cancer of Testis
- Cancer of Uterus
- Cancer of Uterus and Cervix
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, during, and 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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
California
-
Compton, California, United States, 90220
- Recruiting
- DxTerity Diagnostics
-
Contact:
- Kristen Warren
- Phone Number: 310-537-7857
- Email: kwarren@dxterity.com
-
Contact:
- Yaneli Arevalo
- Phone Number: 310-537-7857
- Email: yarevalo@dxterity.com
-
Principal Investigator:
- Robert Terbrueggen, PhD
-
-
Florida
-
Bradenton, Florida, United States, 34202
- Recruiting
- 21st Century Oncology
-
Principal Investigator:
- John Sylvester, MD
-
Contact:
- Rachel Novella, RN
- Phone Number: 239-938-9315
- Email: Rachel.Novella@21co.com
-
Fort Myers, Florida, United States, 33908
- Recruiting
- 21st Century Oncology
-
Principal Investigator:
- Constantine Mantz, MD
-
Contact:
- Rachel Novella, RN
- Phone Number: 239-938-9315
- Email: Rachel.Novella@21co.com
-
Plantation, Florida, United States, 33324
- Recruiting
- 21st Century Oncology
-
Contact:
- Rachel Novella, RN
- Phone Number: 239-938-9315
- Email: Rachel.Novella@21co.com
-
Principal Investigator:
- Christopher Chen, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female patients age 18 or older
- Have a permanent address in the United States for the duration of the study
- Have an email address and access to the internet 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
Exclusion Criteria:
1. Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obtain pre- and post-irradiation participant-collect blood samples
Time Frame: 1.5 years
|
Obtain pre-irradiation participant-collected blood samples as well subsequent 3 participant-collected blood samples and associated clinical data from cancer patients undergoing abdominal/pelvic radiation therapy as part of clinical care.
|
1.5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Testicular Diseases
- Liver Diseases
- Prostatic Diseases
- Head and Neck Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Esophageal Diseases
- Colorectal Neoplasms
- Gallbladder Diseases
- Biliary Tract Diseases
- Pancreatic Diseases
- Anus Diseases
- Biliary Tract Neoplasms
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Testicular Neoplasms
- Prostatic Neoplasms
- Ovarian Neoplasms
- Urinary Bladder Neoplasms
- Rectal Neoplasms
- Pancreatic Neoplasms
- Liver Neoplasms
- Esophageal Neoplasms
- Colonic Neoplasms
- Anus Neoplasms
- Uterine Neoplasms
- Gallbladder Neoplasms
Other Study ID Numbers
- DXT-RADTOX-AC03
- HHSN261201600051C (Other Grant/Funding Number: National Cancer Institute (NCI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
-
University of Wisconsin, MadisonCompletedCancer Survivor | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Healthy Subject | Stage I Colorectal Cancer | Stage IIIA Colorectal Cancer | Stage IIIB Colorectal Cancer | Stage... and other conditionsUnited States