NCT05328960

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

April 13, 2022

Last Update Submit

December 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Yearly incidence of rectal cancer

    The number of patients diagnosed yearly 2019, 2020, 2021 and 2022

    2019-2022

Secondary Outcomes (4)

  • Symptoms at diagnosis

    6 months prior diagnosis

  • Patient's delay

    12 months prior diagnosis

  • Doctor's delay

    12 months prior diagnosis

  • Treatment changes

    Diagnosis and 12 months following

Study Arms (1)

Patients diagnosed before, during or after the pandemic

Patients with rectal cancer

Other: Diagnosed during or not during the pandemic

Interventions

We will create a group of patients that are diagnosed before and after the pandemic and one group diagnosed during the pandemic

Patients diagnosed before, during or after the pandemic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Rectal cancer diagnosis 2019-2022

You may not qualify if:

  • No rectal cancer diagnosis 2019-2022

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Eva Angenete, MD. PhD

CONTACT

Anette Wedin, RN

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 14, 2022

Study Start

February 15, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations