NCT03133286

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

April 24, 2017

Last Update Submit

August 5, 2024

Conditions

Radiation TherapyCancerCancer of AnusCancer of BladderCancer of CervixCancer of ColonCancer of RectumCancer of EsophagusCancer of GallbladderCancer of LiverCancer of OvaryCancer of PancreasCancer of ProstateCancer of Kidney and Renal PelvisCancer of StomachCancer of TestisCancer of UterusCancer of Uterus and CervixCancer of Kidney

Keywords

Anal CancerBladderCervicalColorectalEsophagealGallbladderLiverOvarianPancreasPancreaticProstateRectalRenalKidneyStomachTesticularUterineCancerRadiation TherapyRadiation Treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    1.5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients diagnosed with a primary gastrointestinal (GI), genitourinary (GU), or gynecological (GYN) tumors being treated with radiation therapy.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

DxTerity Diagnostics

Compton, California, 90220, United States

Location

21st Century Oncology

Bradenton, Florida, 34202, United States

Location

21st Century Oncology

Fort Myers, Florida, 33908, United States

Location

21st Century Oncology

Plantation, Florida, 33324, United States

Location

MeSH Terms

Conditions

NeoplasmsAnus NeoplasmsUrinary Bladder NeoplasmsUterine Cervical NeoplasmsColonic NeoplasmsRectal NeoplasmsEsophageal NeoplasmsGallbladder NeoplasmsLiver NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsProstatic NeoplasmsKidney NeoplasmsStomach NeoplasmsTesticular NeoplasmsUterine Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesLiver DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesKidney DiseasesStomach DiseasesTesticular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 28, 2017

Study Start

April 6, 2017

Primary Completion

February 24, 2020

Study Completion

February 25, 2020

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)