NCT04083547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

September 5, 2019

Last Update Submit

November 3, 2020

Conditions

Circulating Tumor CellPeritoneal MetastasesHyperthermic Intraperitoneal Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Prognostic value

    Prediction of survival and recurrence according to the occurrence of CTCs.

    2 year.

Study Arms (1)

HIPEC group

All patients undergoing HIPEC will asked to join this prospective study.

Diagnostic Test: iCellate

Interventions

iCellateDIAGNOSTIC_TEST

New method of circulating tumour cell detection and capture.

HIPEC group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akademiska Sjukhuset (Uppsala University hospital)

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 10, 2019

Study Start

October 17, 2017

Primary Completion

October 1, 2019

Study Completion

November 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

SE(1)