Bile Duct Cancer, Colorectal Cancer (CRC), Digestive Cancers, Hepatocellular Cancer (HCC), Pancreatic Cancer, Rectal Cancer
Conditions
Keywords
digestive, cancer, tumours, cholangiocarcinoma, hepatocellular, colorectal, pancreas, rectal
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.
Interventions
None listed
Sponsors
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Situation of digestive tumours in Spain | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Generate knowledge and scientific evidence on events and situations that may impact on digestive tumours (e.g. COVID-19 coronavirus pandemic). |
| 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 | Subjects may consent in translational projects (i.e. biomarkers determination, NGS or DNA analysis, etc), with banked biological samples |
| 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 | Determination of molecular markers that may be useful healthcare decision-making in patients diagnosed with digestive tumours. |
Countries
Spain
Contacts
Primary ContactEsther Mahillo, PhD
Outcome results
None listed