Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Micrometastasis in Gastrointestinal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01919151
Recruitment Status : Unknown
Verified August 2013 by Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : August 8, 2013
Last Update Posted : August 12, 2013
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease
Pancreatic Adenocarcinoma Colorectal Cancer

Detailed Description:
Oncological and overall outcome of the included patients are consecutively registrated at the out-patient clinic. At end of follow-up these survival data are analysed according to the presence of tumor cells in blood and bone marrow, and the prognostic impact of their presence are assessed.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Process of Metastasis in Colorectal Cancer Tumour Biology and Prognostic Factors in Pancreatic Cancer
Study Start Date : June 2008
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Gastrointestinal cancer patients
Patients with radiological suspected cancer in the pancreas Patients with radiological suspected colorectal liver metastasis


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Survival [ Time Frame: 5 year ]

Biospecimen Retention:   Samples With DNA
Blood and bone marrow cells fixated to slides or to cartridge. Some fresh frozen tumor samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Gastrointestinal cancer patients:

  1. patients with suspected adenocarcinoma in the pancreas
  2. patients with liver metastases secondary to colorectal cancer
Criteria

Inclusion Criteria:

  1. Histological proven adenocarcinoma of the pancreas
  2. Histological/radiological verified colorectal liver metastases
  3. Consent capable patient
  4. Signed written, informed consent

Exclusion Criteria:

1. Patient'history of other malignancy

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919151


Contacts
Layout table for location contacts
Contact: Gro Wiedswang, MD,PhD +4722119550 uxgrie@ous-hf.no
Contact: Evi Faleide, MD,PhD +4722118080 UXEVAL@us-hf.no

Locations
Layout table for location information
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Gro Wiedswang, MD,PhD    +47 22119550    uxgrie@ous-hf.no   
Principal Investigator: Gro Wiedswang, MD,PhD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Study Chair: Bjørn Atle Bjørnbeth, MD,PhD Oslo University Hospital, Dep of Gastrointestinal surgery
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01919151    
Other Study ID Numbers: 93-08172d6.2008.540
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013
Keywords provided by Oslo University Hospital:
survival
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases