Clinical trial NCT06711211: Spanish Registry of Digestive Tumours RETUD
Official title: A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with digestive tumours in healthcare centres of Spain.

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.

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.

Primary outcomes:
measure: Situation of digestive tumours in Spain
timeFrame: 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:
measure: Knowledge about situations that can impact digestive tumours
timeFrame: 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
measure: Biological substudies for translational reseach of tumor diagestive diseases
timeFrame: 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
measure: Determination of molecular markers
timeFrame: 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:
Locations:
city: Madrid
country: Spain
facility: Grupo de Tratamiento de los Tumores Digestivos (TTD)
Study officials:
References: