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In-depth characterization of gastrointestinal tumors for personalized therapy

In-depth characterization of gastrointestinal tumors for personalized therapy - Precise trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036037
Enrollment
1200
Registered
2025-01-29
Start date
2025-04-10
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Histologically proven or suspected gastrointestinal tumor (e.g. esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer, cholangiocarcinoma, hepatocellular carcinoma, gastrointestinal neuroendocrine neoplasia)

Interventions

Group 1: Patients with histologically proven or suspected gastrointestinal tumors scheduled for elective tumor resection/biopsy will be recruited for this trial.

Sponsors

Universitätsklinik für Allgemeine-, Viszerale- und Transplantationschirurgie Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Histologically proven or suspected gastrointestinal tumor (e.g. esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer, cholangiocarcinoma, hepatocellular carcinoma, gastrointestinal neuroendocrine neoplasia) on cross-sectional imaging with planned surgical resection/biopsy - = 18 years of age - Capacity for consent and written informed consent - Patient considered to tolerate surgery

Exclusion criteria

Exclusion criteria: - American Society of Anesthesiologists (ASA) score > III - Inability to comply with study and/or follow-up procedures - (language) problems in understanding the patient information document explaining the present clinical trial - Any condition which could result in an undue risk for the patient in the opinion of the investigator

Design outcomes

Primary

MeasureTime frame
Comprehensive characterization of tumor heterogeneity in gastrointestinal tumors

Secondary

MeasureTime frame
- Determination of the spatial distribution, density, composition, mutation and activation status of intratumoral cell types (immune, stroma, epithelial cells) and tumor-infiltrating microbes on single cell level. - Assessment/prediction of therapy response using ex vivo tumor models (e. g. organoids, tissue slice cultures) - Assessment of perioperative tumor cell dissemination (circulating tumor cells, CTCs) and heterogeneity (e.g. clonal, transcriptional) of disseminated tumor cells - Assessment of parameters of gastrointestinal tumors to delineate their biological relevance, i.e. survival, recurrence, metastatic potential, or response to adjuvant therapy - Identification of therapeutic targets and clinically relevant markers, which might improve patient stratification, to predict prognosis, or therapy response

Countries

Germany

Contacts

Public ContactSusanne Roth

Universitätsklinik für Allgemeine-, Viszerale- und Transplantationschirurgie Tübingen

susanne.roth@med.uni-tuebingen.de+4970712968589

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026