Trial Outcomes & Findings for Colorectal Cancer: Screening vs. Non-Screening (NCT NCT02727894)

Results Overview

Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group. * 0\. stage (Tis N0 M0) * I. stage (T1-2 N0 M0) * II. stage (T3-4 N0 M0) * III. stage (T1-4 N1-2 M0) * IV. stage (T1-4 N1-2 M1) Stages 0,I II were considered to have better outcome

Recruitment status

COMPLETED

Target enrollment

276 participants

Primary outcome timeframe

at time of diagnosis

Results posted on

2019-03-05

Participant Flow

From March 2013 till September 2015 in 12 centres across the Czech Republic 276 patients were enrolled.

Patients with diagnosed colorectal carcinoma were enrolled (276). 11 patients were excluded because of the inability to categorise those patients into the screening or non-screening group.

Participant milestones

Participant milestones
Measure	Screening Group CRC diagnosed by screening was defined as cancer diagnosed by primary screening colonoscopy, or colonoscopy after a positive immunochemical based faecal occult blood test (iFOBT) in patients without symptoms invited to examination according to the national screening programme policy	Non-screening Group Symptomatic CRC was defined as cancer diagnosed in symptomatic patients.
Overall Study STARTED	73	192
Overall Study COMPLETED	73	192
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Colorectal Cancer: Screening vs. Non-Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screening n=73 Participants Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after FOBT).	Others n=192 Participants Patients with colorectal cancer diagnosed by other diagnostic procedures (diagnostic colonoscopy, CT, magnetic resonance, ultrasonography, urgent surgery, etc.)	Total n=265 Participants Total of all reporting groups
Age, Customized Age (years, median)	67.5 years n=5 Participants	70 years n=7 Participants	68 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	77 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	115 Participants n=7 Participants	159 Participants n=5 Participants

PRIMARY outcome

Timeframe: at time of diagnosis

Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group. * 0\. stage (Tis N0 M0) * I. stage (T1-2 N0 M0) * II. stage (T3-4 N0 M0) * III. stage (T1-4 N1-2 M0) * IV. stage (T1-4 N1-2 M1) Stages 0,I II were considered to have better outcome

Outcome measures

Outcome measures
Measure	Screening Group n=73 Participants Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after iFOBT).	Non-Screening Group n=192 Participants Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
Colorectal Cancer Stage (pTNM)	46 Participants	85 Participants

SECONDARY outcome

Timeframe: after surgery was performed

Differences between colorectal cancer grade in screening vs. non-screening group. * GX (cannot be identified) * G1 (well diff.) * G2 (moderately diff.) * G3 (poorly diff.) * G4 (undifferentiated) Grades 1,2 were considered to have connection with lower stage

Outcome measures

Outcome measures
Measure	Screening Group n=73 Participants Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after iFOBT).	Non-Screening Group n=192 Participants Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
Colorectal Cancer Grade	53 Participants	120 Participants

SECONDARY outcome

Timeframe: after surgery was performed

Difference between colorectal cancer resection margins (RX, R0, R1, R2) in screening vs. non-screening group. * RX: cannot be identified * R0: no cancer cells seen microscopically at the resection margin * R1: cancer cells present microscopically at the resection margin (microscopic positive margin) * R2: gross examination by the naked eye shows tumor tissue present at the resection margin (macroscopic positive margin)

Outcome measures

Outcome measures
Measure	Screening Group n=62 Participants Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after iFOBT).	Non-Screening Group n=154 Participants Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
Colorectal Cancer Resection Margins	48 Participants	94 Participants

SECONDARY outcome

Timeframe: at time of diagnosis

Differences between occurrence of colorectal cancer metastasis (MX, M0, M1) between screening vs. non-screening group. * MX: cannot be measured * M0: cancer has not spread to other parts of the body * M1: cancer has spread to other parts of the body

Outcome measures

Outcome measures
Measure	Screening Group n=73 Participants Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after iFOBT).	Non-Screening Group n=192 Participants Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
Colorectal Cancer Metastasis	55 Participants	104 Participants

SECONDARY outcome

Timeframe: time between diagnosis and surgery, measured after surgery was performed

Median time between diagnosis and surgery.

Outcome measures

Outcome measures
Measure	Screening Group n=73 Participants Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after iFOBT).	Non-Screening Group n=192 Participants Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
Colorectal Cancer Surgery	30 Number of day betw. diagnosis and surg. Interval 24.0 to 35.0	21.5 Number of day betw. diagnosis and surg. Interval 19.0 to 24.0

SECONDARY outcome

Timeframe: during treatment plan setting

Differences between neoadjuvant, adjuvant and systemic palliative therapy in screening vs. non-screening group. Number of patients treated with palliative therapy in both groups.

Outcome measures

Outcome measures
Measure	Screening Group n=73 Participants Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after iFOBT).	Non-Screening Group n=192 Participants Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.
Colorectal Cancer and Palliative Therapy	2 Participants	23 Participants

Adverse Events

Screening Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-screening Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jan Král

Institution for Clinical and Experimental Medicine

Phone: +420605273008

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results can be published exclusively by the main investigator or after main investigator approval.
Publication restrictions are in place

Restriction type: OTHER