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Radiotherapy Assessments During Intervention ANd Treatment (RADIANT) (RADIANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03133286
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
DxTerity Diagnostics

Brief Summary:
Collect blood samples and associated clinical data prior to, during, and post radiation treatment.

Condition or disease
Radiation Therapy Cancer Cancer of Anus Cancer of Bladder Cancer of Cervix Cancer of Colon Cancer of Rectum Cancer of Esophagus Cancer of Gallbladder Cancer of Liver Cancer of Ovary Cancer of Pancreas Cancer of Prostate Cancer of Kidney and Renal Pelvis Cancer of Stomach Cancer of Testis Cancer of Uterus Cancer of Uterus and Cervix Cancer of Kidney

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).


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiotherapy Assessments During Intervention ANd Treatment (RADIANT)
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : September 6, 2019
Estimated Study Completion Date : September 6, 2019





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) tumors being treated with radiation therapy.
Criteria

Inclusion Criteria:

  1. Male and female patients age 18 or older
  2. Have a permanent address in the United States for the duration of the study
  3. Have an email address and access to the internet for the duration of the study
  4. Diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) cancer
  5. Planned radiation therapy to the abdominal/pelvic area as part of clinical care
  6. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133286


Contacts
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Contact: Kristen Warren 310-537-7857 kwarren@dxterity.com
Contact: Yaneli Arevalo 310-537-7857 yarevalo@dxterity.com

Locations
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United States, California
DxTerity Diagnostics Recruiting
Compton, California, United States, 90220
Contact: Kristen Warren    310-537-7857    kwarren@dxterity.com   
Contact: Yaneli Arevalo    310-537-7857    yarevalo@dxterity.com   
Principal Investigator: Robert Terbrueggen, PhD         
United States, Florida
21st Century Oncology Recruiting
Bradenton, Florida, United States, 34202
Contact: Rachel Novella, RN    239-938-9315    Rachel.Novella@21co.com   
Principal Investigator: John Sylvester, MD         
21st Century Oncology Recruiting
Fort Myers, Florida, United States, 33908
Contact: Rachel Novella, RN    239-938-9315    Rachel.Novella@21co.com   
Principal Investigator: Constantine Mantz, MD         
21st Century Oncology Recruiting
Plantation, Florida, United States, 33324
Contact: Rachel Novella, RN    239-938-9315    Rachel.Novella@21co.com   
Principal Investigator: Christopher Chen, MD         
Sponsors and Collaborators
DxTerity Diagnostics
National Cancer Institute (NCI)

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Responsible Party: DxTerity Diagnostics
ClinicalTrials.gov Identifier: NCT03133286     History of Changes
Other Study ID Numbers: DXT-RADTOX-AC03
HHSN261201600051C ( Other Grant/Funding Number: National Cancer Institute (NCI) )
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DxTerity Diagnostics:
Anal Cancer
Bladder
Cervical
Colorectal
Esophageal
Gallbladder
Liver
Ovarian
Pancreas
Pancreatic
Prostate
Rectal
Renal
Kidney
Stomach
Testicular
Uterine
Cancer
Radiation Therapy
Radiation Treatment

Additional relevant MeSH terms:
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Anus Diseases
Pancreatic Neoplasms
Prostatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Uterine Cervical Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Ovarian Neoplasms
Urinary Bladder Neoplasms
Anus Neoplasms
Gallbladder Neoplasms
Uterine Neoplasms
Testicular Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases