Radiotherapy Assessments During Interve… | Clinical Trial

Key information

Conditions

Radiation Therapy Adnexal Diseases Anus Diseases Anus Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Cancer Cancer Of Prostate Cancer of Anus Cancer of Bladder Cancer of Cervix Cancer of Colon Cancer of Esophagus Cancer of Gallbladder Cancer of Kidney Cancer of Kidney and Renal Pelvis Cancer of Liver Cancer of Ovary Cancer of Pancreas Cancer of Rectum Cancer of Stomach Cancer of Testis Cancer of Uterus Cancer of Uterus and Cervix Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Stomach Diseases Stomach Neoplasms Testicular Diseases Testicular Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DxTerity Diagnostics, Compton, California, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Receipt of radiation within three (3) months to abdominal/pelvic area prior to scheduled start of Radiation Treatment

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

DxTerity Diagnostics

Industry

Collaborators

National Cancer Institute (NCI)

Registry information

Acronym: RADIANT

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Apr 28, 2017
Registry last updated: Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed