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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with digestive tumours in healthcare centres of Spain.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Mahillo, PhD | Contact | +34913788275 | ttd@ttdgroup.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grupo de Tratamiento de los Tumores Digestivos (TTD) | Recruiting | Madrid | Madrid | 28007 | Spain |
All IPD that underlie results in a publication or a presentation to a scientific congress or meeting
At cohort interim analysis, regularly, average of one update per year
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.
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D008113 | Liver Neoplasms |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| D009369 | Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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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.
| 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 | 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 | Determination of molecular markers that may be useful healthcare decision-making in patients diagnosed with digestive tumours. | 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 |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D008107 | Liver Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |