Colorectal Surgery for Stage II / III Primary Colorectal CancerNCT04353882
Mu Opioid Receptor 1 Expression and Activation Patterns in Colorectal Cancer
An observational study of Colorectal Surgery for Stage II / III Primary Colorectal Cancer, run by Hospital Universitario La Fe.
Trial summary
Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery for Stage II / III Primary Colorectal Cancer
- What is being tested?
- Assess the difference in MOR-1 expression between healthy and tumor tissue
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jun 2022
- Phase
- Observational
- 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
Study population: Patients undergoing scheduled colorectal surgery for stage II and III primary colorectal cancer during the period 01/01/2010 and 12/31/2014.
Who may be able to join
- Patients over 18 years of age.
- Colorectal surgery scheduled between January 2010 - December 2014.
- Stage II or III colon or rectum neoplasm (T3 / T4 N + M0).
Who cannot join
- Neoplasia of colon or rectum in Stage I or Stage IV.
- Non-oncological colorectal surgery.
- Urgent surgery
About this study
Official title: Evaluation of the Difference in Expression of the Mu Type 1 Opioid Receptor and of the Markers of Its Activation (Cyclic Adenosine Monophosphate and Protein Kinase A) in Colorectal Cancer. Case-control Study in Patients With Tumor Recurrence Versus Disease-free Patients at 5 Years.
Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery.
Read the detailed description
Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery. Period January 2010-December 2014. Patients must have had at least 5 years of follow-up to define disease-free survival. From the cohort of patients previously studied in our center by immunohistochemistry, 31 we will select 10 cases with recurrence by random sampling and we will match 10 controls by leveling the propensity score (propensity score matching).
- Being tested
- Assess the difference in MOR-1 expression between healthy and tumor tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess the difference in MOR-1 expression between healthy and tumor tissueOther
Assess the difference in the quantitative expression of MOR-1 (by means of RT-qPCR) between healthy tissue and tumor tissue, in patients with stage II and III colorectal cancer undergoing scheduled surgery.
| Study group | Role | What they receive |
|---|---|---|
| patients with tumor recurrence | Not described Receives: Other: Assess the difference in MOR-1 expression between healthy and tumor tissue | |
| patients with-out tumor recurrence | Not described Receives: Other: Assess the difference in MOR-1 expression between healthy and tumor tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOR-1 expression by polymerase chain reaction (RT-qPCR) in tumor tissue and adjacent healthy tissue.
Measured: Day 1
Secondary outcomes (3)
Cancer-free survival 5 years after surgery (disease-free survival-DFS).
Measured: Day 1
Degree of MOR-1 activation measured by immunohistochemistry through cAMP and PKA levels.
Measured: Day 1
MOR-1 expression by immunohistochemistry in tumor tissue and adjacent healthy tissue.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Surgery for Stage II / III Primary 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353882
- Sponsor's protocol ID
- MOROCCO-II
- Status last verified
- May 2020
- First submitted
- 16 Apr 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Difference in Expression of the Mu Type 1 Opioid Receptor and of the Markers of Its Activation (Cyclic Adenosine Monophosphate and Protein Kinase A) in Colorectal Cancer. Case-control Study in Patients With Tumor Recurrence Versus Disease-free Patients at 5 Years.
- ClinicalTrials.gov ID
- NCT04353882
- Acronym / sponsor ID
- MOROCCO-II
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 21 Apr 2020 (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.
Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery.
Detailed description
Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery. Period January 2010-December 2014. Patients must have had at least 5 years of follow-up to define disease-free survival. From the cohort of patients previously studied in our center by immunohistochemistry, 31 we will select 10 cases with recurrence by random sampling and we will match 10 controls by leveling the propensity score (propensity score matching).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with tumor recurrence | – | Other: Assess the difference in MOR-1 expression between healthy and tumor tissue |
| patients with-out tumor recurrence | – | Other: Assess the difference in MOR-1 expression between healthy and tumor tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing scheduled colorectal surgery for stage II and III primary colorectal cancer during the period 01/01/2010 and 12/31/2014.
Key inclusion criteria (3 listed)
- Patients over 18 years of age.
- Colorectal surgery scheduled between January 2010 - December 2014.
- Stage II or III colon or rectum neoplasm (T3 / T4 N + M0).
Key exclusion criteria (3 listed)
- Neoplasia of colon or rectum in Stage I or Stage IV.
- Non-oncological colorectal surgery.
- Urgent surgery
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 |
|---|---|---|
| Assess the difference in MOR-1 expression between healthy and tumor tissueAssess the difference in the quantitative expression of MOR-1 (by means of RT-qPCR) between healthy tissue and tumor tissue, in patients with stage II and III colorectal cancer undergoing scheduled surgery. | Other | patients with tumor recurrence, patients with-out tumor recurrence |
Primary outcome
MOR-1 expression by polymerase chain reaction (RT-qPCR) in tumor tissue and adjacent healthy tissue.
Time frame: Day 1
3 secondary outcomes
Cancer-free survival 5 years after surgery (disease-free survival-DFS).
Time frame: Day 1
Degree of MOR-1 activation measured by immunohistochemistry through cAMP and PKA levels.
Time frame: Day 1
MOR-1 expression by immunohistochemistry in tumor tissue and adjacent healthy tissue.
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery for Stage II / III Primary Colorectal Cancer, run by Hospital Universitario La Fe.
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 3 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: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
MOR-1 expression by polymerase chain reaction (RT-qPCR) in tumor tissue and adjacent healthy tissue. (time frame: Day 1). 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 19 May 2020.