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Micrometastasis in Gastrointestinal Cancer

NCT ID: NCT01919151

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Adenocarcinoma Colorectal Cancer

Keywords

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survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastrointestinal cancer patients

Patients with radiological suspected cancer in the pancreas Patients with radiological suspected colorectal liver metastasis

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bjørn Atle Bjørnbeth, MD,PhD

Role: STUDY_CHAIR

Oslo University Hospital, Dep of Gastrointestinal surgery

Locations

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Oslo University Hospital

Oslo, Oslo County, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Gro Wiedswang, MD,PhD

Role: CONTACT

Phone: +4722119550

Email: [email protected]

Evi Faleide, MD,PhD

Role: CONTACT

Phone: +4722118080

Email: [email protected]

Facility Contacts

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Gro Wiedswang, MD,PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33198661 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30216219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28258416 (View on PubMed)

Other Identifiers

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93-08172d6.2008.540

Identifier Type: -

Identifier Source: org_study_id