NCT04422002

Brief Summary

The purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

4.1 years

First QC Date

June 2, 2020

Last Update Submit

February 13, 2024

Conditions

Colorectal CancerSurgeryFrailty

Outcome Measures

Primary Outcomes (1)

  • Survival

    1 year

Secondary Outcomes (1)

  • Surgical complications

    30 days

Study Arms (2)

Surgical treatment

Palliative treatment

Eligibility Criteria

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

Adults with a recent diagnostic of localised colorectal cancer and a positive frailty screening

You may qualify if:

  • Localised colorectal cancer
  • Positive frailty screening

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporacio Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Colorectal NeoplasmsFrailty

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 9, 2020

Study Start

December 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

ES(1)