Solid malignancies: colorectal cancer, hepatocellular carcinoma, esophageal cancer, adenocarcinoma of the esophagogastric junction (AEG), gastric cancer, pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, sarcomas, breast cancer, cervical cancer, ovarian cancer, lung cancer, prostate cancer, renal cell carcinoma, melanoma, and head and neck malignancies.
Conditions
Interventions
Group 1: Patients with solid malignancies are enrolled after written informed consent in this prospective multicenter observational study. At baseline, clinical characteristics, laboratory parameters,
all assessments are based on routine clinical care data and biospecimens.
Sponsors
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with a solid malignancy Written informed consent for study participation Age = 18 years (oder: 18 years of age or older)
Exclusion criteria
Exclusion criteria: Second primary malignancy diagnosed within the previous 5 years (excluding basal cell carcinoma, cutaneous squamous cell carcinoma, carcinoma in situ, intraepithelial neoplasia, and thyroid microcarcinoma) Absence of written informed consent Carcinoma of unknown primary (CUP) Primary central nervous system malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of the study is tumor vessel infiltration. Tumor vessel infiltration is determined either radiologically in routine clinical CT imaging or histologically after tumor resection. The data will be collected at first study visit and during routine tumor entity-specific follow-up visits for up to three years after enrollment or until death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include overall survival, the longitudinal development and progression of tumor vessel infiltration, the association between tumor vessel infiltration and body composition parameters such as cachexia, sarcopenia and myosteatosis, the identification of clinical, radiological and molecular predictors of tumor vessel infiltration, the identification of serum biomarkers associated with tumor vessel infiltration and its progression, and the impact of local and systemic therapies, including vessel resection, on tumor vessel infiltration and long-term outcomes. These outcomes are assessed at baseline and during routine tumor entity-specific follow-up visits for up to three years after enrollment or until death. Data are collected from routine clinical records, laboratory parameters, radiological imaging (CT/MRI), histopathological findings, treatment and follow-up documentation, as well as molecular analyses of blood and tumor tissue samples. | — |
Countries
Germany, Italy, United States
Contacts
Public ContactLouisa Bolm
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Outcome results
None listed