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NCT Number: NCT06711211

Spanish Registry of Digestive Tumours RETUD

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.

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Key information

Conditions

Digestive Cancers Adenocarcinoma Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Colonic Diseases Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatocellular Cancer (HCC) Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grupo de Tratamiento de los Tumores Digestivos (TTD)

Madrid, 28007, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Mahillo, PhD

CONTACT

[email protected]

+34913788275

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours

Acronym: RETUD

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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