The Pandemic's Effect on Diagnosis and Treatment of Recta... | NCT05328960

Studies
The Pandemic's Effect on Diagnosis and Treatment of Rectal Cancer

NCT05328960

Sponsor

Sahlgrenska University Hospital

Status

Unknown status

Last Update Posted

Dec 8, 2023Actual

Enrollment

8,000Estimated

Phase

Not provided

Conditions

Rectal Cancer

Interventions

Diagnosed during or not during the pandemic

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Apr 13, 2022

First Submission Date that Met QC Criteria

Apr 13, 2022

First Posted Date

Apr 14, 2022Actual

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 7, 2023

Last Update Posted Date

Dec 8, 2023Actual

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

Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown.

The aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients diagnosed before, during or after the pandemic		Patients with rectal cancer	Other: Diagnosed during or not during the pandemic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnosed during or not during the pandemic	Other	We will create a group of patients that are diagnosed before and after the pandemic and one group diagnosed during the pandemic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Yearly incidence of rectal cancer	The number of patients diagnosed yearly 2019, 2020, 2021 and 2022	2019-2022

Secondary Outcomes

Measure	Description	Time Frame
Symptoms at diagnosis	Symptoms at diagnosis as reported by patients	6 months prior diagnosis
Patient's delay	Delay from symptoms until doctors appointment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rectal cancer diagnosis 2019-2022

Exclusion Criteria:

No rectal cancer diagnosis 2019-2022

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 that are diagnosed with rectal cancer and identified in the Swedish ColoRectal Cancer Registry will be included. They will be contacted by phone and mail regarding a questionnaire.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eva Angenete, MD. PhD	Contact	0760514441		eva.angenete@vgregion.se
Anette Wedin, RN	Contact			anette.wedin@vgregion.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Surgery, Sahlgrenska University Hospital/Ostra	Recruiting	Gothenburg		SE 416 85	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided