Influence of Opioid Analgesia on Circulating Tumor Cells... | NCT03700541

Studies
Influence of Opioid Analgesia on Circulating Tumor Cells in Laparoscopic Colorectal Cancer Surgery

NCT03700541

Sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Status

Completed

Last Update Posted

Dec 7, 2023Actual

Enrollment

71Actual

Phase

Phase 4

Conditions

Colorectal Cancer
Circulating Tumor Cell

Interventions

Morphine
Piritramid

Countries

Czechia

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

Sep 2023

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

Jan 7, 2019Actual

Primary Completion Date

Nov 1, 2023Actual

Completion Date

Dec 6, 2023Actual

First Submitted Date

Oct 3, 2018

First Submission Date that Met QC Criteria

Oct 7, 2018

First Posted Date

Oct 9, 2018Actual

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

Dec 6, 2023

Last Update Posted Date

Dec 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

The Institute of Molecular and Translational Medicine, Czech RepublicOTHER

Collaborators

Name	Class
General University Hospital, Prague	OTHER
Tomas Bata Hospital, Czech Republic	OTHER
University Hospital Ostrava	OTHER
Hospital Novy Jicin

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

To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Morphine	Active Comparator	Morphine-based perioperative analgesia	Drug: Morphine
Piritramid	Active Comparator	Piritramid-based perioperative analgesia	Drug: Piritramid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Morphine	Drug	Morphine intravenous	Morphine
Piritramid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery	Baseline number of circulating tumor cells will be recorded prior to surgery in a venous blood sample. Number of circulating tumor cells will be measured 2 - 4 weeks after surgery in a venous blood sample. These two values will be compared.	1 - 3 days before surgery to 4 weeks after surgery

Secondary Outcomes

Measure	Description	Time Frame
Pain assessment	Pain intensity assessed using Numerical Rating Scale (0-10)	Time Frame: 3 days postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing open radical surgery for colorectal cancer
age over 18 years
signed informed consent

Exclusion Criteria:

intolerance of the study drugs
history of CRC surgery
neoadjuvant therapy
other malignancy not in permanent remission
chronic opioid medication or opioid administration within 7 days preoperatively
immunosuppressive or corticosteroid therapy
surgery within 30 days preoperatively (except minor)
chronic or acute infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marian Hajduch, MD PhD	Institute of Molecular and Translational Medicine, Palacky University, Olomouc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
T. Bata Regional Hospital Zlin		Zlin	South Moravian	76275	Czechia
University Hospital Ostrava

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D009360	Neoplastic Cells, Circulating

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine
D010892	Pirinitramide

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided