NCT04045236

Brief Summary

The primary purpose of this registry is to prospectively collect data from different Mini-invasive Colo-rectal Units in Northern Italy with a standardization of the pre-operative, intra-operative and post operative setting for patients operated on for non metastatic rectal cancer with curative intent. The secondary aim is to collect in a registry the compliance to oncological treatments and the oncological outcomes for the same patients

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

July 30, 2019

Last Update Submit

March 21, 2023

Conditions

Non Metastatic Rectal Cancer

Outcome Measures

Primary Outcomes (4)

  • Disease free survival

    Survival rate

    at 5 years from surgery

  • Over all survival

    Survival rate

    at 5 years from surgery

  • Local recurrences

    Recurrences rate

    at 5 years from surgery

  • Distant recurrence

    Recurrences rate

    at 5 years from surgery

Secondary Outcomes (1)

  • Quality of life Scale (QOLS)

    at 5 years from surgery

Study Arms (1)

Non metastatic rectal cancer

Patients receiving the diagnosis of non metastatic rectal cancer and the indication for a curative treatment will be enrolled in the registry. The study population will consist of all the patients enrolled in the participating centres from the start of the rectal cancer registry on.

Other: Registry

Interventions

RegistryOTHER

Data collection

Non metastatic rectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving the diagnosis of non metastatic rectal cancer and the indication for a curative treatment will be enrolled in the registry. The study population will consist of all the patients enrolled in the participating centres from the start of the rectal cancer registry on.

You may qualify if:

  • non metastatic rectal cancer with the indication for a curative treatment

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italia, 20162, Italy

Location

MeSH Terms

Interventions

Registries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 5, 2019

Study Start

October 1, 2021

Primary Completion

December 1, 2021

Study Completion

September 1, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

IT(1)