NCT04430231

Brief Summary

This work is an original clinical research article describing the relationship between wait list tome for colorectal cancer patients and long-term survival. These findings are particularly relevant for management of surgical wait lists during crisis such as the Covid-19 pandemic. The lack of a relationship between wait list time and disease free survival and tendency for improved survival in the 4-6 week imply some colorectal cancer operations can be safely delayed during times of limited resources.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

6 years

First QC Date

June 10, 2020

Last Update Submit

June 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Disease-free overall survival

    5 years

Study Arms (4)

Wait list time 0-2 weeks

Wait list time 0-2 weeks

Other: Wait list time

Wait list time 2-4 weeks

Wait list time 2-4 weeks

Other: Wait list time

Wait list time 4-6 weeks

Wait list time 4-6 weeks

Other: Wait list time

Wait list time > 6 weeks

Wait list time \> 6 weeks

Other: Wait list time

Interventions

Wait list time 0-2 weeksWait list time 2-4 weeksWait list time 4-6 weeksWait list time > 6 weeks

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who had American Joint Committee on Cancer (AJCC) stage I through III confirmed adenocarcinomas were selected, with "colon" or "upper rectum" as their primary site of malignancy according to International Classification of Diseases for Oncology, Third Edition topography code.

You may qualify if:

  • American Joint Committee on Cancer (AJCC) stage I through III confirmed adenocarcinomas
  • With "colon" or "upper rectum" as their primary site of malignancy according to International Classification of Diseases for Oncology, Third Edition topography code.

You may not qualify if:

  • Emergency surgery,
  • More than one primary site,
  • Synchronous metastasis or peritoneal carcinomatosis at the time of surgery
  • If they received neoadjuvant chemoradiotherapy
  • If they had a local transanal excision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

January 1, 2012

Primary Completion

December 31, 2017

Study Completion

April 1, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06