Spanish Registry of Digestive Tumours RETUD

NCT06711211 | Recruiting DMC

• 1 other identifier: TTD-20-01 RETUD RETUD
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

digestive; cancer; tumours; cholangiocarcinoma; hepatocellular; colorectal; pancreas; rectal

Outcome Measures

Primary Outcomes (1)

• Situation of digestive tumours in Spain

  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 Outcomes (3)

• 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

• 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

• 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

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with digestive tumours in healthcare centres of Spain.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Grupo de Tratamiento de los Tumores Digestivos (TTD)

Madrid, Madrid, 28007, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Frozen or formalin-fixed and paraffin-embedded tumour tissue samples, primary or metastatic, to be accompanied whenever possible by frozen or formalin-fixed and paraffin-embedded non-tumour tissue from the patient. * Liquid samples: Blood for obtaining serum and plasma. * By-products derived from these samples, such as circulating free DNA, circulating tumour cells, DNA, RNA, proteins, etc. Samples are obtained from patients undergoing surgery and/or from biopsies for diagnosis or treatment of the digestive tumours specified, always as part of the health care provided to them.

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Bile Duct Neoplasms; Liver Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Rectal Neoplasms; Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Liver Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Esther Mahillo, PhD

CONTACT

+34913788275; ttd@ttdgroup.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 2, 2024
• Study Start: December 23, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: At cohort interim analysis, regularly, average of one update per year
• 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.

Locations

ES (1)