NCT02143115

Brief Summary

The goal of this study is to compare the findings of virtual (CT-colonography) with findings of optical colonoscopies to determine if virtual colonoscopy is suitable for colorectal cancer surveillance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

5 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

August 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

4.8 years

First QC Date

May 15, 2014

Last Update Submit

November 29, 2016

Conditions

Colorectal Cancer

Keywords

Colorectal cancer surveillance

Outcome Measures

Primary Outcomes (1)

  • Compare the test characteristics (sensitivity, specificity, positive and negative predictive value) of Computed Tomography colonography (CT-C) in the post Colorectal cancer resection using optical colonoscopy as the reference standard

    To evaluate the test characteristics (sensitivity, specificity, positive and negative predictive value) of CT colonography (CT-C) for detecting colorectal adenomas and cancers in the post-CRC resection surveillance setting, using optical colonoscopy (OC) as the reference standard.

    One year post colorectal cancer resection

Secondary Outcomes (1)

  • Compare the costs and outcomes of Computed Tomography Colonography versus independent Optical Colonoscopy plus Computed Tomography for post Colorectal Cancer resection surveillance.

    One year post colorectral cancer resection

Interventions

Optical colonoscopyPROCEDURE

Examination of the colon with a colonoscope

CT-ColonographyRADIATION

A computerized X-ray that may find out if there are polyps or cancers and also pictures the contents of the abdomen and pelvis

Also known as: CT-C or virtual colonoscopy

Eligibility Criteria

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

Patients with a history of colorectal cancer

You may qualify if:

  • Patients with a history of CRC without clear evidence of metastatic disease who have completed their acute cancer-specific treatment
  • Patients aged 18 years or older
  • Patients who have signed an approved informed consent form

You may not qualify if:

  • Patients with a diverting ileostomy, with a history of inflammatory bowel disease, FAP, or active GI symptoms (gastrointestinal bleed, diarrhea, severe abdominal pain, etc.)
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (3)

  • Weinberg DS, Mitnick J, Keenan E, Li T, Ross EA. Post-operative colorectal cancer surveillance: preference for optical colonoscopy over computerized tomographic colonography. Cancer Causes Control. 2019 Nov;30(11):1269-1273. doi: 10.1007/s10552-019-01231-w. Epub 2019 Sep 17.

    PMID: 31531798DERIVED

  • Kupfer SS, Lubner S, Coronel E, Pickhardt PJ, Tipping M, Graffy P, Keenan E, Ross E, Li T, Weinberg DS. Adherence to postresection colorectal cancer surveillance at National Cancer Institute-designated Comprehensive Cancer Centers. Cancer Med. 2018 Nov;7(11):5351-5358. doi: 10.1002/cam4.1678. Epub 2018 Oct 18.

    PMID: 30338661DERIVED

  • Weinberg DS, Pickhardt PJ, Bruining DH, Edwards K, Fletcher JG, Gollub MJ, Keenan EM, Kupfer SS, Li T, Lubner SJ, Markowitz AJ, Ross EA. Computed Tomography Colonography vs Colonoscopy for Colorectal Cancer Surveillance After Surgery. Gastroenterology. 2018 Mar;154(4):927-934.e4. doi: 10.1053/j.gastro.2017.11.025. Epub 2017 Nov 22.

    PMID: 29174927DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • David S Weinberg, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 20, 2014

Study Start

August 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(5)