Circulating Tumour Cells in Patients With Peritoneal Metastases

November 3, 2020 updated by: Uppsala University

Cirkulerande Tumörceller Hos Patienter Med Bukhinnespridda tumörer

This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due to gastrointestinal cancers that have spread to the peritoneum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CTCs har extracted by way of a new method at baseline, during surgery, and postoperatively. The occurence of such CTCs will be investigated for prognostic evaluation. Patients will be follow-up by Clinical routine. Disease recurrence and overall survival will be the endpoint used.

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Akademiska Sjukhuset (Uppsala University hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients being treated in Uppsala with CRS and HIPEC will be asked to join the study.

Description

Inclusion Criteria:

  • Peritoneal metastases being treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIPEC group
All patients undergoing HIPEC will asked to join this prospective study.
Diagnostic test: iCellate
New method of circulating tumour cell detection and capture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value
Time Frame: 2 year.
Prediction of survival and recurrence according to the occurrence of CTCs.
2 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 17, 2017

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

November 1, 2020

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (ACTUAL)

September 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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