NCT04571047

Brief Summary

We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Our hypothesis is that delaying start of treatment until 4-8 weeks is as safe as starting treatment within four weeks after a colorectal cancer diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

September 2, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

December 2, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

September 2, 2020

Last Update Submit

December 1, 2021

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival

    3 years

Secondary Outcomes (4)

  • Length of stay

    90 days

  • Re-operations within 3 months

    90 days

  • Re-admissions within 3 months

    90 days

  • Radical surgery

    90 days

Study Arms (1)

Colorectal cancer patients

Patients diagnosed with colonrectal cancer between 2008-2016

Other: Time to treatment

Interventions

Time to treatmentOTHER

Treatment before or after 4 weeks after diagnosis

Colorectal cancer patients

Eligibility Criteria

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

All patients registered with a diagnosis of colorectal cancer in Sweden between 2008-2016

You may qualify if:

  • Diagnosed with colorectal cancer 2008-2016 in Sweden

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41132, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Time-to-Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Eva Angenete

    Sahlgrenska Universitetssjukhuset

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of surgery

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 30, 2020

Study Start

October 15, 2020

Primary Completion

July 15, 2021

Study Completion

September 15, 2021

Last Updated

December 2, 2021

Record last verified: 2021-12

Locations

SE(1)