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Circulating Tumour Cells in Patients With Peritoneal Metastases

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04083547
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
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.

Condition or disease Intervention/treatment
Circulating Tumor Cell Peritoneal Metastases Hyperthermic Intraperitoneal Chemotherapy Diagnostic Test: iCellate

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cirkulerande Tumörceller Hos Patienter Med Bukhinnespridda tumörer
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 31, 2019

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.

Primary Outcome Measures :
  1. Prognostic value [ Time Frame: 2 year. ]
    Prediction of survival and recurrence according to the occurrence of CTCs.

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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients being treated in Uppsala with CRS and HIPEC will be asked to join the study.

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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 identifier (NCT number): NCT04083547

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Contact: Peter Cashin, MD PhD +46 186174304

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Akademiska Sjukhuset (Uppsala University hospital) Recruiting
Uppsala, Sweden, 75185
Contact: Peter Cashin, M.D. Ph.D    +46 18 6174304   
Principal Investigator: Peter Cashin, MD, PhD         
Sub-Investigator: Christer Ericsson, MD, PhD         
Sponsors and Collaborators
Uppsala University
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Responsible Party: Uppsala University Identifier: NCT04083547    
Other Study ID Numbers: CTC study
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Cells, Circulating
Neoplastic Processes
Pathologic Processes