- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01919151
Micrometastasis in Gastrointestinal Cancer
The Process of Metastasis in Colorectal Cancer Tumour Biology and Prognostic Factors in Pancreatic Cancer
Prognostic and predictive value of assessing the patients micrometastasis status in blood and bone marrow when diagnosed GI cancer. 2 different patient subgroups are currently studied, patients with cancer of the pancreas and patients with liver metastasis secondary to colorectal cancer.
Our hypothesis is that patients with detective circulating tumor cells in the blood or disseminated tumour cells in their bone marrow at diagnosis have a more advanced disease than negative patients. This information may be of therapeutic interest.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Gro Wiedswang, MD,PhD
- Phone Number: +4722119550
- Email: uxgrie@ous-hf.no
Study Contact Backup
- Name: Evi Faleide, MD,PhD
- Phone Number: +4722118080
- Email: UXEVAL@us-hf.no
Study Locations
-
-
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Oslo, Norway, 0424
- Recruiting
- Oslo University Hospital
-
Contact:
- Gro Wiedswang, MD,PhD
- Phone Number: +47 22119550
- Email: uxgrie@ous-hf.no
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Principal Investigator:
- Gro Wiedswang, MD,PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Gastrointestinal cancer patients:
- patients with suspected adenocarcinoma in the pancreas
- patients with liver metastases secondary to colorectal cancer
Description
Inclusion Criteria:
- Histological proven adenocarcinoma of the pancreas
- Histological/radiological verified colorectal liver metastases
- Consent capable patient
- Signed written, informed consent
Exclusion Criteria:
1. Patient'history of other malignancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Gastrointestinal cancer patients
Patients with radiological suspected cancer in the pancreas Patients with radiological suspected colorectal liver metastasis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: 5 year
|
5 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Bjørn Atle Bjørnbeth, MD,PhD, Oslo University Hospital, Dep of Gastrointestinal surgery
Publications and helpful links
General Publications
- Hugenschmidt H, Labori KJ, Brunborg C, Verbeke CS, Seeberg LT, Bendigtsen Schirmer C, Renolen A, Borgen E, Naume B, Wiedswang G. Cytokeratin-positive cells in the bone marrow from patients with pancreatic, periampullary malignancy and benign pancreatic disease show no prognostic information. BMC Cancer. 2020 Nov 16;20(1):1107. doi: 10.1186/s12885-020-07510-z.
- Hugenschmidt H, Labori KJ, Brunborg C, Verbeke CS, Seeberg LT, Schirmer CB, Renolen A, Borgen EF, Naume B, Wiedswang G. Circulating Tumor Cells are an Independent Predictor of Shorter Survival in Patients Undergoing Resection for Pancreatic and Periampullary Adenocarcinoma. Ann Surg. 2020 Mar;271(3):549-558. doi: 10.1097/SLA.0000000000003035.
- Seeberg LT, Brunborg C, Waage A, Hugenschmidt H, Renolen A, Stav I, Bjornbeth BA, Borgen E, Naume B, Brudvik KW, Wiedswang G. Survival Impact of Primary Tumor Lymph Node Status and Circulating Tumor Cells in Patients with Colorectal Liver Metastases. Ann Surg Oncol. 2017 Aug;24(8):2113-2121. doi: 10.1245/s10434-017-5818-2. Epub 2017 Mar 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 93-08172d6.2008.540
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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