Accuracy and Predictive Values for Colorectal Cancer of Quantitative FIT in Symptomatic Patients in Primary Care

NCT05156307 | Unknown

• 1 other identifier: 275691
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine accuracy and predictive values for colorectal cancer of a faecal quantitative immunochemical test (FIT) in unselected symptomatic patients presenting in primary care. Main reference test will be linkage to a nationwide colorectal cancer registry.

Conditions

Colorectal Cancer

Keywords

Quantitative faecal immunochemical test, symptomatic, primary care

Outcome Measures

Primary Outcomes (1)

• Colorectal cancer

  Linkage to cancer registry

  2 years

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥ 40 years presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible. This involves referral for any endoscopic or radiological examination of the large bowel, laboratory testing, including faecal occult blood test according to local routines, or clinical follow-up within soon. Both urgent referrals and patients planned for at least initial management in primary care are eligible, ie there will be no attempt to delimitate the study population based on any categorization of symptoms into "alarm" and "non-alarm" symptoms. The study population will be defined by primary care physicians´ clinical reasoning and assessment of colorectal cancer as a (more or less) possible diagnosis at the unique consultation.

You may qualify if:

• Patients presenting in primary care with symptoms associated with colorectal cancer prompting their GP to take actions are eligible.

You may not qualify if:

• Referral for bowel examination for other reasons than symptoms. Not able to understand the instructions for participation.

Sponsors & Collaborators

• Region Örebro County: lead
• Region Jämtland Härjedalen: collaborator
• Region Östergötland: collaborator
• Uppsala County Council, Sweden: collaborator
• Dalarna County Council, Sweden: collaborator
• Landstinget i Värmland: collaborator

Study Sites (1)

Skebäcks VC

Örebro, 702 15, Sweden

RECRUITING

Related Publications (1)

• Loov A, Hogberg C, Lilja M, Theodorsson E, Hellstrom P, Metsini A, Olsson L. Diagnostic accuracy for colorectal cancer of a quantitative faecal immunochemical test in symptomatic primary care patients: a study protocol. Diagn Progn Res. 2022 Aug 18;6(1):16. doi: 10.1186/s41512-022-00129-7.

  PMID: 35978403 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Louise Olsson, MD, PhD

  Region Örebro län, Camtö

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Lööv, MD

CONTACT

+46735454965; anna.loov@regionorebrolan.se

Louise Olsson, MD, PhD

CONTACT

+46721413970; louise.olsson@regionorebrolan.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: May 20, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: December 14, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)