Micrometastasis in Gastrointestinal Cancer | NCT01919151

Studies
Micrometastasis in Gastrointestinal Cancer

NCT01919151

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Aug 12, 2013Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Pancreatic Adenocarcinoma
Colorectal Cancer

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Aug 7, 2013

First Submission Date that Met QC Criteria

Aug 7, 2013

First Posted Date

Aug 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2013

Last Update Posted Date

Aug 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gastrointestinal cancer patients		Patients with radiological suspected cancer in the pancreas Patients with radiological suspected colorectal liver metastasis

Interventions

Not provided

Measure	Description	Time Frame
Survival		5 year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Gastrointestinal cancer patients:

patients with suspected adenocarcinoma in the pancreas
patients with liver metastases secondary to colorectal cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gro Wiedswang, MD,PhD	Contact	+4722119550		uxgrie@ous-hf.no
Evi Faleide, MD,PhD	Contact	+4722118080		UXEVAL@us-hf.no

Overall Officials

Name	Affiliation	Role
Bjørn Atle Bjørnbeth, MD,PhD	Oslo University Hospital, Dep of Gastrointestinal surgery	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital	Recruiting	Oslo	Oslo	0424	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33198661	Derived	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.
30216219

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site