NCT02488161

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

June 16, 2015

Last Update Submit

August 23, 2016

Conditions

Colorectal Cancer

Keywords

Colorectal cancerRisk factorsAdverse eventsPredictive models

Outcome Measures

Primary Outcomes (1)

  • Mortality

    up to five years

Secondary Outcomes (5)

  • Number of participants with Readmission

    up to five years

  • Number of participants with Reintervention

    up to five years

  • Changes in health-related quality of life (in the questionnaires employed in the study)

    up to five years

  • Number of participants with Complications

    up to five years

  • Number of participants with Cancer recurrence

    up to five years

Study Arms (1)

Patients with colorectal cancer

One cohort of patients with colorectal cancer, studied before the intervention, and one month, one year, two years, three years and five years after.

Other: No intervention

Interventions

No interventionOTHER
Patients with colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This prospective cohort study included patients drawn from 22 hospitals belonging to the Spanish National Health Service (SNS), which covers the majority (99.8%) of the population of Spain. All covered residents have free access to their primary care physician and to the ED of the hospitals. All of the hospitals have similar technological and human resources. Patients with a diagnosis of colon or rectum cancer attending the surgical services of any of these hospitals to undergo surgery between June 2010 and December 2012 were informed of the goals of the study and invited to voluntarily participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Orive 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: 36892600DERIVED

  • Orive 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: 35737143DERIVED

  • Quintana 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: 34893952DERIVED

  • Gonzalez 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: 34446044DERIVED

  • Quintana 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: 31485982DERIVED

  • Mar 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.

    PMID: 31140003DERIVED

  • Orive M, Aguirre U, Gonzalez N, Lazaro S, Redondo M, Bare M, Anula R, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Quintana JM; REDISSEC-CARESS/CCR group. Risk factors affecting hospital stay among patients undergoing colon cancer surgery: a prospective cohort study. Support Care Cancer. 2019 Nov;27(11):4133-4144. doi: 10.1007/s00520-019-04683-7. Epub 2019 Feb 22.

    PMID: 30793242DERIVED

  • Quintana JM, Anton-Ladisla A, Gonzalez N, Lazaro S, Bare M, Fernandez de Larrea N, Redondo M, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S; REDISSEC-CARESS/CCR group. Outcomes of open versus laparoscopic surgery in patients with colon cancer. Eur J Surg Oncol. 2018 Sep;44(9):1344-1353. doi: 10.1016/j.ejso.2018.05.030. Epub 2018 Jun 6.

    PMID: 29921557DERIVED

  • Mar J, Anton-Ladislao A, Ibarrondo O, Arrospide A, Lazaro S, Gonzalez N, Bare M, Callejo D, Redondo M, Quintana JM; REDISSEC-CARESS/CCR group. Cost-effectiveness analysis of laparoscopic versus open surgery in colon cancer. Surg Endosc. 2018 Dec;32(12):4912-4922. doi: 10.1007/s00464-018-6250-9. Epub 2018 Jun 4.

    PMID: 29869084DERIVED

  • Arostegui I, Gonzalez N, Fernandez-de-Larrea N, Lazaro-Aramburu S, Bare M, Redondo M, Sarasqueta C, Garcia-Gutierrez S, Quintana JM; REDISSEC CARESS-CCR Group. Combining statistical techniques to predict postsurgical risk of 1-year mortality for patients with colon cancer. Clin Epidemiol. 2018 Mar 6;10:235-251. doi: 10.2147/CLEP.S146729. eCollection 2018.

    PMID: 29563837DERIVED

  • Bare M, Alcantara MJ, Gil MJ, Collera P, Pont M, Escobar A, Sarasqueta C, Redondo M, Briones E, Dujovne P, Quintana JM; CARESS-CCR Study Group. Validity of the CR-POSSUM model in surgery for colorectal cancer in Spain (CCR-CARESS study) and comparison with other models to predict operative mortality. BMC Health Serv Res. 2018 Jan 29;18(1):49. doi: 10.1186/s12913-018-2839-x.

    PMID: 29378647DERIVED

  • Quintana JM, Gonzalez N, Anton-Ladislao A, Redondo M, Bare M, Fernandez de Larrea N, Briones E, Escobar A, Sarasqueta C, Garcia-Gutierrez S, Aguirre U; REDISSEC-CARESS/CCR group. Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project. BMC Cancer. 2016 Jul 8;16:435. doi: 10.1186/s12885-016-2475-y.

    PMID: 27391216DERIVED

Biospecimen

Retention: NONE RETAINED

Fragments of colon or rectum obtained in the surgical intervention

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jose M Quintana, PhD

    Hospital Galdakao-Usansolo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 16, 2015

First Posted

July 2, 2015

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

June 1, 2015

Last Updated

August 24, 2016

Record last verified: 2016-08