Clinical trial · Observational
Factors Related to Adverse Events in Colorectal Cancer
Risk Factors of Adverse Outcomes at Short and Medium Term, and Development of Predictive Models, in Patients With Colorectal Cancer. IRYSS-coordinated Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Coordinated multi-center project with several complementary goals in each one of the sub-projects included. Objectives: 1.To determine risk factors of death, or major complications in the short term; 2.To determine risk factors of death, tumor recurrence, major complications, readmission or deterioration of quality of life in the mid term; 3.Evaluation of patient reported outcomes from before the intervention to the end of the follow-up. 4.To study the role of immunohisto-chemistry markers in the prediction of similar adverse results. This sub-project (coordinator) will approach the determination of risk factors of death, tumor recurrence, major complications, readmission and deterioration of quality of medium term life (1-2 years). Methodology. Design: prospective cohort study with 2 years follow-up after the surgical intervention. Participant centers: 18 hospitals of 6 Autonomous Communities of all Spain. Patients diagnosed of colorectal cancer surgically intervened. Variables: pre-intervention, those of the hospital admission, sociodemographic, immunohisto-chemistry and clinical parameters, that could be in relation to the outcomes to study. Statistic analysis: a derivation sample will be created where the possible predicting parameters will be identified, by cancer of colon or rectum. Predictive models will be created with a good discriminative capacity. A validation of those models will be performed in a validation sub-sample. Logistic and Cox regression models will be used. Simulation models for the prediction of discreet events in the long term will be used.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with colorectal cancer
- description
- One cohort of patients with colorectal cancer, studied before the intervention, and one month, one year, two years, three years and five years after.
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Mortality
- timeFrame
- up to five years
Secondary outcomes (5)
- measure
- Number of participants with Readmission
- timeFrame
- up to five years
- measure
- Number of participants with Reintervention
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients were eligible for the study if they were included in the surgical waiting list of one of the participating hospitals with a diagnosis of surgically resectable colon or rectum cancer. Colon or rectum cancer diagnosis was based on anatomopathological diagnosis after a biopsy by colonoscopy. Inclusion criteria were having diagnosed with colon cancer (up to 15 cm above the anal margin) and rectum (between the anal margin and 15 cm above it), where curative and / or palliative surgery for treatment by first time were applied and who sign the informed consent to participate in the study consent. Exclusion Criteria: * Exclusion criteria were colon or rectum in situ cancer, unresectable tumor, severe mental or physical conditions which preclude the patient to respond to questionnaires, terminal patients, patients unable to respond to questionnaires from any cause or who do not give their consent to participate in the study.
References
Publications (12)
- DERIVEDOrive M, Barrio I, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Cortajarena S, Bilbao A, Aguirre U, Sarasqueta C, Quintana JM; REDISSEC-CARESS/CCR group. Five-year follow-up mortality prognostic index for colorectal patients. Int J Colorectal Dis. 2023 Mar 9;38(1):64. doi: 10.1007/s00384-023-04358-0. PMID 36892600
- DERIVEDOrive M, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, Fernandez de Larrea N, Redondo M, Bilbao A, Sarasqueta C, Aguirre U, Quintana JM; REDISSEC-CARESS/CCR group. Anxiety, depression, health-related quality of life, and mortality among colorectal patients: 5-year follow-up. Support Care Cancer. 2022 Oct;30(10):7943-7954. doi: 10.1007/s00520-022-07177-1. Epub 2022 Jun 23. PMID 35737143
- DERIVEDQuintana JM, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Aguirre U, Briones E, Group FTRCR. Quality Indicators and Outcomes in a Prospective Cohort of Colorectal Cancer Patients. J Gastrointest Cancer. 2023 Mar;54(1):20-26. doi: 10.1007/s12029-021-00779-8. Epub 2021 Dec 10. PMID 34893952
- DERIVEDGonzalez N, Lorono A, Aguirre U, Lazaro S, Bare M, Redondo M, Briones E, Sarasqueta C, Bilbao A, de Larrea NF, Quintana JM; REDISSEC-CARESS/CCR group. Risk scores to predict mortality 2 and 5 years after surgery for colorectal cancer in elderly patients. World J Surg Oncol. 2021 Aug 26;19(1):252. doi: 10.1186/s12957-021-02356-6. PMID 34446044
- DERIVEDQuintana JM, Anton-Ladislao A, Lazaro S, Gonzalez N, Bare M, de Larrea NF, Redondo M, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S; REDISSEC CARESS-CCR (Results and Health Services Research in Colorectal Cancer)- group. Predictors of readmission and reoperation in patients with colorectal cancer. Support Care Cancer. 2020 May;28(5):2339-2350. doi: 10.1007/s00520-019-05050-2. Epub 2019 Sep 4. PMID 31485982
- DERIVEDMar J, Anton-Ladislao A, Ibarrondo O, Arrospide A, Lazaro-Aramburu S, Gonzalez N, Bare M, Escobar A, Redondo M, Quintana JM; REDISSEC-CARESS/CCR group. Stage- and age-adjusted cost-effectiveness analysis of laparoscopic surgery in rectal cancer. Surg Endosc. 2020 Mar;34(3):1167-1176. doi: 10.1007/s00464-019-06867-y. Epub 2019 May 28.