Spanish Registry of Digestive Tumours RETUD

Recruiting

• Conditions: Digestive Cancers; Bile Duct Cancer; Hepatocellular Cancer (HCC); Colorectal Cancer (CRC); Pancreatic Cancer; Rectal Cancer

• Registration Number: NCT06711211
• Lead Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Brief Summary

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.

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 Timeline

• Study Start: 2020-12-23
• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Situation of digestive tumours in Spain	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.

Secondary Outcome Measures

Name	Time	Method
Knowledge about situations that can impact digestive tumours	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).
Biological substudies for translational reseach of tumor diagestive diseases	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
Determination of molecular markers	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.

Trial Locations

Locations (1)

Grupo de Tratamiento de los Tumores Digestivos (TTD); 🇪🇸 Madrid, Spain