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Study of the Predictive and Prognostic Role of Pharmacogenetic and Radiogenic Variants on the Response to Neoadjuvant Chemoradiation Therapy in Patients With Locally Advanced Rectal Cancer

NCT ID: NCT06616870

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-03

Study Completion Date

2029-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Exclusion Criteria

1. evidence of secondary tumour
2. inadequate liver function (bilirubin \>1.5 times the normal range, ALT and AST \>2 times the normal range);
3. inadequate renal function (creatinine \>1.5 times the upper limit of normal range);
4. Major concomitant systemic diseases that contraindicate surgery;
5. significant cardiovascular disease (heart failure, acute myocardial infarction within the last year, active angina, cardiac arrhythmia to be treated, uncontrolled hypertension)
6. systemic disease contraindicating radiotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erika Cecchin, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Locations

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Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, Italy

Site Status

Countries

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Italy

Central Contacts

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Erika Cecchin, PhD

Role: CONTACT

Phone: 0434 659 667

Email: [email protected]

Facility Contacts

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Erika Cecchin, PhD

Role: primary

Other Identifiers

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CRO-2023-77

Identifier Type: -

Identifier Source: org_study_id