Spanish Registry of Digestive Tumours RETUD (RETUD)

November 27, 2024 updated by: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours

The aim of this observational study is to assess the current state of digestive tumours in Spain. By doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients.

The study will investigate the epidemiological, biological, and clinical characteristics of digestive tumors diagnosed in patients aged 18 and older across healthcare centres in Spain. It also aims to generate knowledge and scientific evidence for events and situations that may impact on patients with digestive tumours (e.g. COVID-19 coronavirus pandemic).

Furthermore, subject to the patient's consent, biological samples may be collected for use in translational research projects and for the identification of molecular markers that may be useful in healthcare decision-making.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Data will be collected ambispectively, recording those patients who were diagnosed with digestive tumours before the start of the study (from 2017) and also those who are diagnosed after the start of the study.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Grupo de Tratamiento de los Tumores Digestivos (TTD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with digestive tumours in healthcare centres of Spain.

Description

Inclusion Criteria:

  • Male and female patients ≥18 years old diagnosed with oesophageal cancer, gastric cancer, pancreatic cancer, hepatocarcinoma, gallbladder and bile duct cancer, cancer of the small intestine, appendix and gastrointestinal stroma, colorectal cancer, anal canal cancer or digestive hereditary cancer.
  • Written informed consent available.

Exclusion Criteria:

  • Patient for whom, for whatever reason, it is not possible to know or obtain the information necessary to complete the data collection base.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Biliary Tract Cancer (BTC)
Patients diagnosed with cholangiocarcinoma or gallbladder carcinoma from 01-01-2017.
Hepatocellular Carcinoma (HCC)
Patients with hepatocellular carcinoma primary diagnosed from 01-01-2017 and treated with systemic therapy.
MSI-High Colorectal Cancer (MSI-H CRC)
Patients with MSI-High colorectal cancer (by PCR or IHQ) and primary pathological diagnosis from 01-01-2017.
Pancreatic Cancer
Patients with exocrine pancreatic cancer diagnosed from 01-01-2019.
Rectal Cancer
Patients diagnosed with rectal cancer from 01-01-2019.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Situation of digestive tumours in Spain
Time Frame: For each cohort, an annual data cut-off (12 months) is planned. Epidemiology, therapy and efficacy parameters are analyzed from date of diagnosis to outcome or cut-off date, for registry population (at least baseline visit completed)
Understanding the situation of digestive tumours in Spain, their epidemiology (risk factors, age, sex), biology and clinical manifestations in order to improve the quality of care, optimise diagnosis and treatment, and identify areas for improvement that can benefit patients.
For each cohort, an annual data cut-off (12 months) is planned. Epidemiology, therapy and efficacy parameters are analyzed from date of diagnosis to outcome or cut-off date, for registry population (at least baseline visit completed)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about situations that can impact digestive tumours
Time Frame: An annual data cut-off (12 months) per cohort is planned. Upon specific situations (i.e COVID-19), specific cohorts are open to capture related data
Generate knowledge and scientific evidence on events and situations that may impact on digestive tumours (e.g. COVID-19 coronavirus pandemic).
An annual data cut-off (12 months) per cohort is planned. Upon specific situations (i.e COVID-19), specific cohorts are open to capture related data
Biological substudies for translational reseach of tumor diagestive diseases
Time Frame: Frequency of translational projects is defined for each indivial substudy, with data captured from firts´subject diagnosis to last subject´s outcome at time of database
Subjects may consent in translational projects (i.e. biomarkers determination, NGS or DNA analysis, etc), with banked biological samples
Frequency of translational projects is defined for each indivial substudy, with data captured from firts´subject diagnosis to last subject´s outcome at time of database
Determination of molecular markers
Time Frame: Frequency of translational projects is defined for each indivial substudy, with data captured from firts´subject diagnosis to last subject´s outcome at time of database
Determination of molecular markers that may be useful healthcare decision-making in patients diagnosed with digestive tumours.
Frequency of translational projects is defined for each indivial substudy, with data captured from firts´subject diagnosis to last subject´s outcome at time of database

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTD-20-01 RETUD RETUD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication or a presentation to a scientific congress or meeting

IPD Sharing Time Frame

At cohort interim analysis, regularly, average of one update per year

IPD Sharing Access Criteria

Abstracts, posters, oral presentation to congresses, scientific publication related to RETUD patient cohort analysis, will be shared by statisticians, authors, contributors and referees involved in publication peer-review.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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