Uptake to Colorectal Cancer Screening in Familial-risk Population

Colorectal Cancer Clinical Trial

Official title:

Uptake to Colorectal Cancer Screening in Familiar-risk Population: A Randomized Controlled Trial Comparing Immunochemical Fecal Occult Blood Test With Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567045
• Other study ID #: Colorectal cancer screening
• Status: Completed
• Phase: N/A
• Start date: February 25, 2016
• Est. completion date: March 24, 2020

Study information

• Verified date: August 2020
• Source: Hospital Universitario de Canarias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.

Description:

This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients diagnosed of CRC.

The recruitment process will be programmed through the index case, that will be interviewed to obtain their CRC family history. FDR will be contacted in order to make an appointment in the High-risk CRC Clinic of the participant centers. Randomization will be performed before signing the informed consent to avoid selection bias. A researcher will be responsible to provide detailed information about the study and getting the informed consent. In case of willingness to participate in the study, the FDR will be randomized to one of the following arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined as the percentage of FDR who participate at least in one of the two FIT screening round in the FIT group or who undergo colonoscopy in the other group. Screening uptake will be calculated under the assumption of intention to screen analysis.

The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: March 24, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. FDR with a case index meeting the following conditions: at least one case index < 60 years at diagnosis of the CCR;

2. having = 2 FDRs with CRC regardless the age of the case index at diagnosis;

3. having a sibling with CRC;

4. age <75 years.

Exclusion Criteria:

1. past CRC screening;

2. inflammatory bowel disease or past history of colorectal neoplasia;

3. Family history of hereditary CRC;

4. Abdominal symptoms;

5. Colectomy;

6. Severe comorbidity leading to a poor prognosis (life expectancy < 5 years);

7. Refusal to participate in the study.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Screening Uptake of Colonoscopy and FIT

Intervention

Procedure:
• annual FIT and colonoscopy in case of a positive test
FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.
• colonoscopy with sedation
One-time Colonoscopy with sedation.

Locations

Country	Name	City	State
Spain	María Rodriguez Soler	Alicante
Spain	Cristina Alvarez Urturi, MD	Barcelona	Cataluña
Spain	Maria Teresa Ocaña Bombardo	Barcelona	Cataluña
Spain	Digestive Service, Huc	La Laguna	S/C DE Tenerife
Spain	Inés Castro Novo	Ourense	Galicia
Spain	Patricia Muñoz Garrrido	San Sebastián	País Vasco, Gipuzcoa
Spain	Federico Sopeña Biarge	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Dove-Edwin I, Sasieni P, Adams J, Thomas HJ. Prevention of colorectal cancer by colonoscopic surveillance in individuals with a family history of colorectal cancer: 16 year, prospective, follow-up study. BMJ. 2005 Nov 5;331(7524):1047. Epub 2005 Oct 21. — View Citation

Pappadopulos E, Jensen PS, Chait AR, Arnold LE, Swanson JM, Greenhill LL, Hechtman L, Chuang S, Wells KC, Pelham W, Cooper T, Elliott G, Newcorn JH. Medication adherence in the MTA: saliva methylphenidate samples versus parent report and mediating effect — View Citation

Quintero E, Carrillo M, Gimeno-García AZ, Hernández-Guerra M, Nicolás-Pérez D, Alonso-Abreu I, Díez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5) — View Citation

Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas Á, Andreu M, Carballo F, Morillas JD, Hernández C, Jover R, Montalvo I, Arenas J, Laredo E, Hernández V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andrés M, Teruel G, Peris A, Roncales — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who participate in each screening arm		2 years
Secondary	Efficacy measure: QALYs (Quality adjusted life years).		2 years
Secondary	Costs measure: cost (euros) of the procedures associated with each screening strategy and treatment of advanced neoplastic lesions		2 years