Circulating Tumour Cells in Patients With Peritoneal Meta... | NCT04083547

Studies
Circulating Tumour Cells in Patients With Peritoneal Metastases

NCT04083547

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Nov 4, 2020Actual

Enrollment

114Actual

Phase

Not provided

Conditions

Circulating Tumor Cell
Peritoneal Metastases
Hyperthermic Intraperitoneal Chemotherapy

Interventions

iCellate

Countries

Sweden

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2017Actual

Primary Completion Date

Oct 1, 2019Actual

Completion Date

Nov 1, 2020Actual

First Submitted Date

Sep 5, 2019

First Submission Date that Met QC Criteria

Sep 5, 2019

First Posted Date

Sep 10, 2019Actual

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

Nov 3, 2020

Last Update Posted Date

Nov 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

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.

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

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIPEC group		All patients undergoing HIPEC will asked to join this prospective study.	Diagnostic Test: iCellate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iCellate	Diagnostic Test	New method of circulating tumour cell detection and capture.	HIPEC group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Peritoneal metastases being treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akademiska Sjukhuset (Uppsala University hospital)		Uppsala		75185	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided