Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT00855634
Eligibility Criteria:
Inclusion Criteria:
* suspicion of cancer of the pancreas and an intraoperative histologically proven diagnosis of pancreatic adenocarcinoma.
* intraoperative assessment of tumor as potentially locally resectable
* COHORT 1: Minimal metastatic disease
* COHORT 2: Venous infiltration
* ability to sign the informed consent.
* Karnofsky performance status \> 70.
* Life-expectancy of more than 3 months.
* able to attend follow-up.
* no previous or concurrent malignancy diagnoses, except non-melanoma skin cancer and in situ carcinoma of the cervix.
* no serious medical, psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up.
* patients older than 18 years.
* no pregnant or lactating women.
* preoperative evaluation by thin-sliced CT scans with:
* No evidence of substantial extra-pancreatic disease, i.e. no evidence of malignant ascites, extended liver metastasis (\>5 metastatic lesions), spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs.
* No evidence of extension of the tumor into the celiac axis or superior mesenteric artery (T4 disease).
* intraoperative findings with:
* tumor assessed as potentially locally resectable.
* no signs of peritoneal metastasis or tumor manifestations outside of the pancreas and the liver.
* frozen section: adenocarcinoma
Exclusion Criteria:
* extrapancreatic disease (except minimal metastatic disease of the liver, see above)
* concomitant venous infiltration and minimal metastatic disease
* extension of the tumor into the celiac axis or superior mesenteric artery
* life expectancy of less than 3 months
* previous or concurrent malignancy diagnosis, except non-melanoma skin cancer and in situ carcinoma of the cervix
* conditions potentially hampering compliance (also inclusion criteria)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00855634
Study Brief:
Protocol Section:
NCT00855634