Colorectal Cancer Clinical Trial
— CRCOfficial title:
Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes
NCT number | NCT02727894 |
Other study ID # | 00023001-2015 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | January 2016 |
Verified date | March 2019 |
Source | Institute for Clinical and Experimental Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after immunochemical based faecal occult blood test) has more favourable clinical-pathological characteristics than colorectal cancer diagnosed for symptoms. We aimed to compare these two groups of patients at the time of diagnosis and confirm the efficiency of the screening programme.
Status | Completed |
Enrollment | 276 |
Est. completion date | January 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - newly diagnosed colorectal cancer Exclusion Criteria: - unsigned informed consent - mental disorder |
Country | Name | City | State |
---|---|---|---|
Czechia | Institute for Clinical and Experimental Medicine | Praha |
Lead Sponsor | Collaborator |
---|---|
Institute for Clinical and Experimental Medicine | Brno University Hospital, Chomutov Hospital, Frýdek-Místek Hospital, Klaudian Hospital Mladá Boleslav, Masaryk Hospital Rakovník, Medic Kral Ltd., Military University Hospital, Prague, Private practice at Hluboká nad Vltavou, The University Hospital Plzen, Tomas Bata Hospital, Czech Republic, Vitkovice Hospital |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Colorectal Cancer Stage (pTNM) | 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 |
at time of diagnosis | |
Secondary | Colorectal Cancer Grade | 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 |
after surgery was performed | |
Secondary | Colorectal Cancer Resection Margins | 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) |
after surgery was performed | |
Secondary | Colorectal Cancer Metastasis | 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 |
at time of diagnosis | |
Secondary | Colorectal Cancer Surgery | Median time between diagnosis and surgery. | time between diagnosis and surgery, measured after surgery was performed | |
Secondary | Colorectal Cancer and Palliative Therapy | Differences between neoadjuvant, adjuvant and systemic palliative therapy in screening vs. non-screening group. Number of patients treated with palliative therapy in both groups. |
during treatment plan setting |
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