Micrometastasis in Gastrointestinal Cancer

Colorectal Cancer Clinical Trial

Official title:

The Process of Metastasis in Colorectal Cancer Tumour Biology and Prognostic Factors in Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01919151
• Other study ID #: 93-08172d6.2008.540
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2013
• Last updated: August 8, 2013
• Start date: June 2008
• Est. completion date: December 2015

Study information

• Verified date: August 2013
• Source: Oslo University Hospital
• Contact: Gro Wiedswang, MD,PhD
• Phone: +4722119550
• Email: uxgrie[@]ous-hf.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Pancreatic Adenocarcinoma

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		5 year	No