Locally Advanced Rectal CancerNCT05893667
Evaluation of Inflammatory Markers in LARC Patients
An observational study of Locally Advanced Rectal Cancer, run by Hospital Pedro Hispano.
Trial summary
Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Inflammatory markers
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 May 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: as in inclusion criteria
Who may be able to join
- patients diagnosed pathologically with rectal adenocarcinomas, located within 12cm from the anal verge (measured by MRI), clinically staged T3-4 and/or N+ and treated with neoadjuvant chemoradiotherapy (nCRT) followed by radical surgery
Who cannot join
- evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or "watch and wait" approach and evidence of inflammatory or hematological disorders
About this study
Official title: Evaluation of Pretreatment Inflammatory Markers in Predicting Response to nCRT and Prognosis in LARC Patients
Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis.
Methods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox regression and Kaplan-Meier analysis were performed.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Inflammatory markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory markersDiagnostic test
analysis of inflammatory scores
| Study group | Role | What they receive |
|---|---|---|
| High levels of inflammatory scores | Not described Receives: Diagnostic Test: Inflammatory markers | |
| Low levels of inflammatory scores | Not described Receives: Diagnostic Test: Inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival Disease-free survival
Measured: 5 years
Secondary outcomes (1)
Pathological response through Ryan Tumor Regression Grade
TRG 1-5; 1- no viable cancer cells; 5- no fibrosis, with extensive residual disease
Measured: at study completion, average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jan 2010
- Primary completion1 Dec 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pedro Hispano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Morais, Hospital Pedro Hispano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893667
- Sponsor's protocol ID
- HPedroHispano
- Status last verified
- Jun 2023
- First submitted
- 17 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pretreatment Inflammatory Markers in Predicting Response to nCRT and Prognosis in LARC Patients
- ClinicalTrials.gov ID
- NCT05893667
- Acronym / sponsor ID
- HPedroHispano
- Conditions
- Locally Advanced Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Hospital Pedro HispanoUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 8 Jun 2023 (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.
Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We aimed to investigate the value of previously described circulating biomarkers as predictors of prognosis.
Methods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox regression and Kaplan-Meier analysis were performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High levels of inflammatory scores | – | Diagnostic Test: Inflammatory markers |
| Low levels of inflammatory scores | – | Diagnostic Test: Inflammatory markers |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- as in inclusion criteria
Key inclusion criteria (1 listed)
- patients diagnosed pathologically with rectal adenocarcinomas, located within 12cm from the anal verge (measured by MRI), clinically staged T3-4 and/or N+ and treated with neoadjuvant chemoradiotherapy (nCRT) followed by radical surgery
Key exclusion criteria (1 listed)
- evidence of distant metastasis at diagnosis, emergent or palliative surgery, local excision or "watch and wait" approach and evidence of inflammatory or hematological disorders
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 |
|---|---|---|
| Inflammatory markersanalysis of inflammatory scores | Diagnostic test | High levels of inflammatory scores, Low levels of inflammatory scores |
Primary outcome
Overall survival Disease-free survival
Time frame: 5 years
1 secondary outcome
Pathological response through Ryan Tumor Regression Grade
Time frame: at study completion, average of 5 years
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 12 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Locally Advanced Rectal Cancer, run by Hospital Pedro Hispano.
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 1 inclusion and 1 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 12 Jun 2023. 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?
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?
Overall survival Disease-free survival (time frame: 5 years). 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 12 Jun 2023.