Colorectal CancerPhase 4POACC-2NCT03700541
Influence of Opioid Analgesia on Circulating Tumor Cells in Laparoscopic Colorectal Cancer Surgery
A Phase 4 study testing Morphine and Piritramid in people with Colorectal Cancer and Circulating Tumor Cell, run by The Institute of Molecular and Translational Medicine, Czech Republic at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Circulating Tumor Cell
- What is being tested?
- Morphine and Piritramid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesCzechia
- Study dates
- 7 Jan 2019to 6 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing open radical surgery for colorectal cancer
- age over 18 years
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
University Hospital Ostrava
Ostrava, 708 52
General University Hospital
Prague, 12808
T. Bata Regional Hospital Zlin
Zlin, South Moravian, 76275
About this study
Official title: Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Laparoscopic Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
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.
- Conditions
- Colorectal Cancer, Circulating Tumor Cell
- Being tested
- Morphine, Piritramid
- Keywords
- Perioperative analgesia, Colorectal Cancer, Circulating Tumor Cell
- Medical subject headings
- Colorectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Morphine intravenous
PiritramidDrug
Piritramid intravenous
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | Morphine-based perioperative analgesia Receives: Drug: Morphine |
| Piritramid | Active comparator | Piritramid-based perioperative analgesia Receives: Drug: Piritramid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 - 3 days before surgery to 4 weeks after surgery
Secondary outcomes (1)
Pain assessment
Pain intensity assessed using Numerical Rating Scale (0-10)
Measured: Time Frame: 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start7 Jan 2019
- Primary completion1 Nov 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague, Tomas Bata Hospital, Czech Republic, University Hospital Ostrava, Hospital Novy Jicin
- Responsible party
- Sponsor
- Investigators
- Marian Hajduch, MD PhD, Principal investigator, Institute of Molecular and Translational Medicine, Palacky University, Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700541
- Sponsor's protocol ID
- POACC-2
- Acronym
- POACC-2
- Status last verified
- Sep 2023
- First submitted
- 3 Oct 2018
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Laparoscopic Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03700541
- Acronym / sponsor ID
- POACC-2 / POACC-2
- Conditions
- Colorectal Cancer, Circulating Tumor Cell
- Keywords
- Perioperative analgesia, Colorectal Cancer, Circulating Tumor Cell
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague, Tomas Bata Hospital, Czech Republic, University Hospital Ostrava, Hospital Novy Jicin
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: MorphineMorphine-based perioperative analgesia |
| Piritramid | Active comparator | Drug: PiritramidPiritramid-based perioperative analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing open radical surgery for colorectal cancer
- age over 18 years
- signed informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineMorphine intravenous | Drug | Morphine |
| PiritramidPiritramid intravenous | Drug | Piritramid |
Primary outcome
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
Time frame: 1 - 3 days before surgery to 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 secondary outcome
Pain assessment
Time frame: Time Frame: 3 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marian Hajduch, MD PhD principal investigator
Institute of Molecular and Translational Medicine, Palacky University, Olomouc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine and Piritramid in people with Colorectal Cancer and Circulating Tumor Cell, run by The Institute of Molecular and Translational Medicine, Czech Republic at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery (time frame: 1 - 3 days before surgery to 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.