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Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment (Tidop)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571047
Recruitment Status : Completed
First Posted : September 30, 2020
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer Other: Time to treatment

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment
Actual Study Start Date : October 15, 2020
Actual Primary Completion Date : July 15, 2021
Actual Study Completion Date : September 15, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Colorectal cancer patients
Patients diagnosed with colonrectal cancer between 2008-2016
 Other: Time to treatment
Treatment before or after 4 weeks after diagnosis


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
    Overall survival


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 90 days ]
    Hospital stay

  2. Re-operations within 3 months [ Time Frame: 90 days ]
    Surgical procedures registered within 3 months after the procedure date

  3. Re-admissions within 3 months [ Time Frame: 90 days ]
    Readmissions registered within 3 months after the procedure date

  4. Radical surgery [ Time Frame: 90 days ]
    Defined as R0 resection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients registered with a diagnosis of colorectal cancer in Sweden between 2008-2016
Criteria

Inclusion Criteria:

  • Diagnosed with colorectal cancer 2008-2016 in Sweden

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571047


Locations
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Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 41132
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Eva Angenete Sahlgrenska Universitetssjukhuset
More Information
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Responsible Party: Eva Angenete, Professor of surgery, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04571047    
Other Study ID Numbers: Tidop
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data is extracted from CRCBaSe, (ColoRectal Cancer Data Base) a combination of several registries in Sweden and thus the sharing option will be decided by that work group

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases