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Spanish Registry of Digestive Tumours RETUD

ConditionsDigestive CancersBile Duct CancerHepatocellular Cancer (HCC)Colorectal Cancer (CRC)Pancreatic CancerRectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Patients diagnosed with digestive tumours in healthcare centres of Spain.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

20,000 Participants
are grouped into 5 trial groups
Group A: Biliary Tract Cancer (BTC)
Group B: Hepatocellular Carcinoma (HCC)
Group C: MSI-High Colorectal Cancer (MSI-H CRC)
Group D: Pancreatic Cancer
Group E: Rectal Cancer

Trial outcomes

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.

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 outcomes

1

Knowledge about situations that can impact digestive tumours

Generate knowledge and scientific evidence on events and situations that may impact on digestive tumours (e.g. COVID-19 coronavirus pandemic).

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
2

Biological substudies for translational reseach of tumor diagestive diseases

Subjects may consent in translational projects (i.e. biomarkers determination, NGS or DNA analysis, etc), with banked biological samples

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
3

Determination of molecular markers

Determination of molecular markers that may be useful healthcare decision-making in patients diagnosed with digestive tumours.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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