Time to Surgery - the Impact of Waiting Time on Outcome A... | NCT04571047

Studies
Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment

NCT04571047

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

40,000Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Time to treatment

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2020Actual

Primary Completion Date

Jul 15, 2021Actual

Completion Date

Sep 15, 2021Actual

First Submitted Date

Sep 2, 2020

First Submission Date that Met QC Criteria

Sep 29, 2020

First Posted Date

Sep 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2021

Last Update Posted Date

Dec 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eva Angenete, Professor of surgery, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colorectal cancer patients		Patients diagnosed with colonrectal cancer between 2008-2016	Other: Time to treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Time to treatment	Other	Treatment before or after 4 weeks after diagnosis	Colorectal cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival	3 years

Secondary Outcomes

Measure	Description	Time Frame
Length of stay	Hospital stay	90 days
Re-operations within 3 months	Surgical procedures registered within 3 months after the procedure date

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with colorectal cancer 2008-2016 in Sweden

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Angenete	Sahlgrenska Universitetssjukhuset	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital		Gothenburg		41132	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061665	Time-to-Treatment

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided