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Recruiting NCT06711211

Spanish Registry of Digestive Tumours RETUD

Observational Digestive Cancers Bile Duct Cancer Hepatocellular Cancer (HCC) Colorectal Cancer (CRC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Digestive Cancers, Bile Duct Cancer, Hepatocellular Cancer (HCC), Colorectal Cancer (CRC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours

Overview

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.

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Grupo de Tratamiento de los Tumores Digestivos (TTD) — Madrid

Identifiers

NCT: NCT06711211 · TTD-20-01 RETUD RETUD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗