An observational study in Rectal Cancer, sponsored by Centro di Riferimento Oncologico - Aviano. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Centro di Riferimento Oncologico - Aviano · Observational
In locally advanced rectal cancer the pathological complete response (pCR) to neoadjuvant chemoradiation therapy (nCRT) is associated with a favourable long-term prognosis. The identification of markers predictive of response to therapy would therefore optimise treatment by allowing personalised therapy. It has been shown that the genetic profile of the patient could influence the activation of the immune system in combination with chemoradiation therapy in targeting tumour cells. In addition, genetic features of molecular pathways correlated with response to chemoradiotherapy, may in turn affect the probability of a good response to treatment in these patients, but also the occurrence of adverse events. The main objective of the study is to define the role of genetic markers related to immune system activation and other molecular pathways in predicting the complete pathological response to preoperative chemoradiation therapy in patients with locally advanced rectal cancer.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 460 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Centro di Riferimento Oncologico - Aviano is the lead sponsor of 47 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a histologically confirmed diagnosis of primary resectable LARC
Eligibility criteria:
Exclusion Criteria:
Defining the predictive role of rare (MAF<1%) and very rare genetic variants (MAF<0.1%) in the SMAD3 and IL-17F genes, implicated in nCRT-mediated activation of the immune system on the pathological tumour response to nCRT in LARC.
Relation between rare and very rare genetic variants and pathological tumour response will be assessed with logistic regression analysis and data will be reported as odds ratio and relative confidence interval
Time frame: up to 5 years
Plasma levels of IL-17F and SMAD3 proteins during treatment to be correlated with the genetic characteristics
Mean difference between subgroup of patients with different genetics characteristics
Time frame: up to 5 years
Plasma levels of IL-17F and SMAD3 proteins during treatment and tumour response
Relation between plasma levels of IL-17F and SMAD3 proteins and pathological tumour response will be assessed with logistic regression analysis and data will be reported as odds ratio and relative confidence interval
Time frame: up to 5 years
Plasma levels of IL-17F and SMAD3 proteins during treatment and prognosis of the tumour.
Relation between plasma levels of IL-17F and SMAD3 and disease-free survival (DFS) defined as time between enrollment and objective tumor progression using Kaplan Meyer method
Time frame: up to 5 years
Identify further genetic markers of pathological tumour response
Relation between selected genetic markers and pathological tumour response will be assessed with logistic regression analysis and data will be reported as odds ratio and relative confidence interval
Time frame: up to 5 years
Define the role of the same genetic polymorphisms on disease-free survival
Relation between selected genetic markers and disease-free survival (DFS) defined as time between enrollment and objective tumor progression using Kaplan Meyer method
Time frame: up to 5 years
Define the role of the same genetic polymorphisms on overall survival of patients
Relation between selected genetic markers and overall survival (OS) defined as time between enrollment and death from any cause using Kaplan Meyer method
Time frame: up to 5 years
Define the role of the same genetic polymorphisms on the risk of developing severe treatment toxicities
Relation between genetic variants and severe treatment toxicity will be assessed with logistic regression analysis and data will be reported as odds ratio and relative confidence interval
Time frame: up to 5 years
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Centro di Riferimento Oncologico - Aviano