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Colorectal AdenomaPhase 4FITSNCT01767870

Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia

A Phase 4 study testing FIT-sigmoidoscopy and Colonoscopy in people with Colorectal Adenoma, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy. Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Adenoma
What is being tested?
FIT-sigmoidoscopy and Colonoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,282 participants
Where
1 siteSouth Korea
Study dates
Aug 2012to Aug 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Asymptomatic subjects aged 45 - 75 years
  • Subjects who will give the written consent

Who cannot join

  • Subjects with past history of colorectal cancer
  • Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC)
  • Subjects with familial history of colorectal cancer more than 2 familial member in direct line
  • Subjects with inflammatory bowel disease(IBD)
  • Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification
  • Subjects with past history of colectomy
Show all 10Show fewer
  • Subjects with history of colonoscopy within 5 years
  • Subjects with history of sigmoidoscopy within 3 years
  • Subjects with history of CT colonoscopy within 10 years
  • Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months

Trial locations and contacts

1 site in 1 country.

Hyun-Soo Kim, M.D., ph D. contact

+82-33-741-1224

hyskim@yonsei.ac.kr

Hong Jun Park, M.D. contact

+82-33-741-1226

ppakongs@daum.net

South Korea1 site, 1 recruiting

  • Wonju Christian Hospital

    Wŏnju, 220-701

    Hyun-Soo Kim, M.D., ph D., +82-33-741-1224, hyskim@yonsei.ac.kr

    Hong Jun Park, M.D., +82-33-741-1226, ppakongs@daum.net

    Recruiting

Other trials in South Korea

About this study

Official title: Efficacy and Cost-effectiveness of Colonoscopy vs. Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia (eCOLO-FITS): A Randomized Multicenter Trial

The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.

Read the detailed description

The investigators will evaluate the efficacy of FITS for the detection of advanced colorectal neoplasia compared to colonoscopy. This study was designed as multicenter randomized interventional study. The expected period are 36months. A total 13 tertiary hospitals will participate in the study.

Subjects will be randomly allocated to FITS group and colonoscopy group. Subjects who undergo FITS will be performed by following colonoscopy to confirm the efficacy of FITS. In colonoscopy group, subjects as a control group would be performed colonoscopy.

Being tested
FIT-sigmoidoscopy, Colonoscopy
Keywords
advanced colorectal adenoma, colonoscopy, sigmoidoscopy, fecal immunochemical test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FIT-sigmoidoscopyProcedure or surgery

    Also called FITS, sigmoidoscopy

    Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy

  • ColonoscopyProcedure or surgery

    Advanced colorectal adenoma detection by colonoscopy

Study groups in NCT01767870
Study groupRoleWhat they receive
FIT-SigmoidoscopyExperimentalThis arm (FIT-Sigmoidoscopy) will take fecal immunochemical test (FIT) followed by sigmoidoscopy for evaluation of advanced colorectal adenoma detection rate. Immediately after sigmoidoscopy, a total colonoscopy will be performed as a standard method for advanced colorectal adenoma detection.
Receives: Procedure: FIT-sigmoidoscopy
ColonoscopyExperimentalThis arm (Colonoscopy) will take a total colonoscopy as a control group that will represent the efficacy of colonoscopy for advanced colorectal adenoma detection rate.
Receives: Procedure: Colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Advanced colorectal adenoma detection rate between two groups

    We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

Secondary outcomes (12)

  1. Sensitivity of fecal immunochemical test for advanced colorectal adenoma

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.

    Measured: on 7days after intervention

  2. Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

  3. Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

  4. positive predictive valueof fecal immunochemical test for advanced colorectal adenoma

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.

    Measured: on 7days after intervention

  5. specificity of fecal immunochemical test for advanced colorectal adenoma

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.

    Measured: on 7days after intervention

  6. negative predictive value of fecal immunochemical test for advanced colorectal adenoma

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.

    Measured: on 7days after intervention

  7. specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

  8. positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

  9. negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

  10. specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

  11. positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

  12. negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer

    We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

    Measured: on 7 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2013 (estimated)
  2. Study startAug 2012
  3. Primary completionAug 2015 (estimated)
  4. Study completionAug 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,282 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01767870
Sponsor's protocol ID
CR312033
Acronym
FITS
Status last verified
Jan 2013
First submitted
19 Dec 2012
Last updated
14 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, Snover DC, Schuman LM. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med. 2000 Nov 30;343(22):1603-7. doi: 10.1056/NEJM200011303432203.

    PubMed 11096167

  • Rozen P, Levi Z, Hazazi R, Waked A, Vilkin A, Maoz E, Birkenfeld S, Niv Y. Quantitative colonoscopic evaluation of relative efficiencies of an immunochemical faecal occult blood test and a sensitive guaiac test for detecting significant colorectal neoplasms. Aliment Pharmacol Ther. 2009 Feb 15;29(4):450-7. doi: 10.1111/j.1365-2036.2008.03898.x. Epub 2008 Nov 17.

    PubMed 19035980

  • Wong WM, Lam SK, Cheung KL, Tong TS, Rozen P, Young GP, Chu KW, Ho J, Law WL, Tung HM, Choi HK, Lee YM, Lai KC, Hu WH, Chan CK, Yuen MF, Wong BC. Evaluation of an automated immunochemical fecal occult blood test for colorectal neoplasia detection in a Chinese population. Cancer. 2003 May 15;97(10):2420-4. doi: 10.1002/cncr.11369.

    PubMed 12733140

  • Launoy GD, Bertrand HJ, Berchi C, Talbourdet VY, Guizard AV, Bouvier VM, Caces ER. Evaluation of an immunochemical fecal occult blood test with automated reading in screening for colorectal cancer in a general average-risk population. Int J Cancer. 2005 Jun 20;115(3):493-6. doi: 10.1002/ijc.20921.

    PubMed 15700317

  • Whitlock EP, Lin JS, Liles E, Beil TL, Fu R. Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Nov 4;149(9):638-58. doi: 10.7326/0003-4819-149-9-200811040-00245. Epub 2008 Oct 6.

    PubMed 18838718

  • Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.

    PubMed 22612596

  • Lieberman DA, Weiss DG; Veterans Affairs Cooperative Study Group 380. One-time screening for colorectal cancer with combined fecal occult-blood testing and examination of the distal colon. N Engl J Med. 2001 Aug 23;345(8):555-60. doi: 10.1056/NEJMoa010328.

    PubMed 11529208

  • Kato J, Morikawa T, Kuriyama M, Yamaji Y, Wada R, Mitsushima T, Yamamoto K. Combination of sigmoidoscopy and a fecal immunochemical test to detect proximal colon neoplasia. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1341-6. doi: 10.1016/j.cgh.2009.04.025. Epub 2009 May 6.

    PubMed 19426835

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FIT-sigmoidoscopy and Colonoscopy in people with Colorectal Adenoma, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hyun-Soo Kim, M.D., ph D. (+82-33-741-1224, hyskim@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Advanced colorectal adenoma detection rate between two groups (time frame: on 7 days after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01767870, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.

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