pancreatic cancer
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The age at the date of obtaining the consent is 20 years or older 2. Resectable invasive pancreatic ductal carcinoma or an IPMC diagnosis of any of the following a. to e. within 60 days prior to enrollment*1 a. Clinical stage 0 pancreatic cancer (TisN0M0)*2 b. Clinical stage IA pancreatic cancer (T1N0M0)*2 c. Clinical stage IB pancreatic cancer (T2N0M0)*2 d. Clinical stage IIA pancreatic cancer (T3N0M0)*2 e. Clinical stage IIB pancreatic cancer (T1-3N1M0)*2 3.Resection of invasive pancreatic ductal carcinoma or IPMC as described in 3.2 is contemplated. 4.No treatment for invasive pancreatic ductal carcinoma or IPMC. 5.Willingness to submit blood and tissue specimens in accordance with the research protocol. 6.Consent has been obtained in writing. *1 The diagnosis of IPMC and clinical stage I-IIB requires that the patient has undergone thoraco-abdominal and pelvic CT or MRI within 60 days prior to enrollment to evaluate lymph node metastases and exclude distant metastases. Patients with allergies/sensitivities to contrast media may be performed without contrast media. *2 Factors T and M of the clinical progression classification (cStage) follow the 8th edition of the UICC TNM classification, and factor N follows the 7th edition of the Pancreatic Cancer Treatment Protocol. *3 Borderline resectable (BR) in the Resectability Classification (Pancreatic Cancer Treatment Protocol, 7th Edition) is subdivided into portal and arterial invasion. BR-PV (portal invasion only; no tumor contact or invasion of the superior mesenteric artery, celiac artery, or common hepatic artery, but contact, invasion, or occlusion of the superior mesenteric vein/portal vein greater than 180 degrees and not extending beyond the inferior duodenal border) is also eligible for enrollment.
Exclusion criteria
Exclusion criteria: 1. A history of malignancy with a disease-free period of up to 5 years.*1 2. Clinically suspected coexistence of cancer of other organs. 3. Women who are pregnant or intend to become pregnant. 4. Your physician determines that you are unsuitable for enrollment in the study. *1 Even if the disease-free period is less than 5 years, a history of cancer with a 5-year relative survival rate equivalent to 95% or higher, such as stage I prostate cancer, stage 0 and stage I laryngeal cancer with complete response to radiotherapy, and completely resected cancer in the following pathological stages, is not excluded and can be registered. Gastric cancer (adenocarcinoma (general type)): stage 0-I, colon cancer (adenocarcinoma): stage 0-I, rectal cancer (adenocarcinoma): stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous cell carcinoma, basal cell carcinoma): stage 0, breast cancer (non-invasive ductal carcinoma, non-invasive lobular carcinoma): stage 0, breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): stage 0-IIA Cancer of the uterus (endometrial adenocarcinoma, mucinous adenocarcinoma): stage IA, prostate cancer (adenocarcinoma): stage I-II, cervical cancer (squamous cell carcinoma): stage IA, thyroid cancer (papillary carcinoma, follicular carcinoma): stage I, II, III, renal cancer (panniculocellular carcinoma, anaplastic pigment cell carcinoma): stage I, other intramucosal cancer equivalent lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LUNAR assay positivity in Stage 0-IIB resectable invasive pancreatic ductal carcinoma and IPMC | — |
Countries
Japan
Contacts
Public ContactYoshiaki Nakamura
National Cancer Center Hospital East Division for the Promotion of Drug and Diagnostic Development
Outcome results
None listed