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Studio Multidimensionale Progettato per Sviluppare un Quadro Metodologico Basato sui Dati di Risonanza Magnetica (MRI) per Predire la Risposta Patologica Completa (pCR) in Pazienti con Cancro del Retto Localmente Avanzato Dopo Trattamento Neoadiuvante (RESTAGE)

5 novembre 2026 aggiornato da: Institut du Cancer de Montpellier - Val d'Aurelle

Studio Multidimensionale Progettato per Sviluppare un Quadro Metodologico Basato sui Dati di Risonanza Magnetica per Predire la Risposta Patologica Completa (pCR) in Pazienti con Cancro del Retto Localmente Avanzato Dopo Trattamento Neoadiuvante

Rectal cancer presents a significant global health challenge. Despite improvements in clinical outcomes, significant disparities persist across Europe. These differences are explained not only by the heterogeneity of risk factors and screening strategies, but also by variations in diagnostic and therapeutic approaches, which are highly dependent on medical imaging.

Standard treatment for locally advanced rectal cancer based on staging MRI is neoadjuvant treatment (NAT), for tumour downsizing and downstaging, followed by total mesorectal excision. In a significant proportion of cases, radical surgery leads to substantial long-term complications like sexual and urinary dysfunction, fecal incontinence, and impairment in daily activities. Given that up to 42% of patients show complete tumor regression at pathology (i.e. pathological complete response pCR), to avoid unnecessary radical surgery, non-operative management has become an attractive alternative when there are no signs of viable tumour after NAT (i.e. clinical complete response cCR). Such patients are candidates for Watch-and-Wait (W&W), an established active surveillance policy in specialized centers worldwide relying on clinical examination, endoscopy and MRI.

On the other hand, W&W carries a risk of local regrowth (persistence of microscopic residual disease despite apparent cCR). Even in expert hands, assessment of tumor response is not perfect and local regrowth based on current selection methods occurs in ~30% of cases. Although deferred surgery is a successful treatment with no apparent negative impact on local disease control, an increased rate of distant metastases has been recently reported.

Therefore, there is a critical unmet clinical need to detect complete responses after NAT and avoid unnecessary surgery with its associated morbidity and quality of life impairment risks, while also improving sensitivity for residual microscopic disease that will result in local regrowth and associated reduced disease-free survival.

Rectal cancer poses a burden not only on healthcare systems, but also on patient well-being. Patients frequently suffer from feelings of isolation and helplessness when faced with unpredicted disease-related situations, given the common difficulties to access high quality information and communicate with attending physicians. As such, there is a clear need to unburden healthcare facilities from unnecessary hospital visits, while improving patient outcomes, engagement, support and care.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

115

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Preclinical phase: For patients requiring surgery after neoadjuvant chemoradiotherapy, a surgical consultation will be scheduled as part of routine care. The study will be explained, and an information sheet provided. Participation requires signing the informed consent by the patient and the investigating surgeon.

Clinical phase: When a patient requires an MRI as part of their standard care, the study will be presented during the radiology consultation with an information sheet. If the patient agrees to participate, the informed consent form must be signed by the patient and the investigating physician.

Patients may be included in the study at two possible times: during the MRI performed before neoadjuvant treatment (MRI staging), or during the re-evaluation MRI after neoadjuvant treatment (MRI restaging).

Descrizione

Inclusion Criteria for the preclinical phase :

  • Age ≥18 years old;
  • Have a confirmed diagnosis of locally advanced rectal cancer;
  • Have completed neoadjuvant chemoradiotherapy;
  • Be a candidate for surgical treatment with total mesorectal excision;
  • Be willing and able to provide written informed consent;
  • Affiliation to the French Social Security System.

Inclusion criteria for the clinical phase:

  • Age ≥18 years old;
  • Have a confirmed diagnosis of locally advanced rectal cancer;
  • Require neoadjuvant chemoradiotherapy or have completed neoadjuvant chemoradiotherapy;
  • Requires either surgical treatment or a non-surgical strategy ("Watch-and-Wait") after neoadjuvant chemoradiotherapy;
  • Be willing and able to provide written informed consent;
  • Affiliation to the French Social Security System.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Phase 1 (Preclinical): An ex-vivo analysis of surgical specimens

15 surgical specimens will be collected after surgery following neoadjuvant treatment. They will be imaged using a 3T MRI with advanced sequences, then returned to the pathology department. This ex vivo MRI will not affect sample preparation or preservation. MRI images will be aligned with histological sections using non-linear registration to compare MRI parameters with digital pathology data. This step will help identify MRI biomarkers that differentiate healthy tissue, post-treatment fibrotic tissue, and residual tumor. We will assess whether diffusion MRI and relaxometry measurements can predict pathological outcomes by analyzing parameters such as fractional anisotropy, mean diffusivity, and kurtosis, using surgical pathological information when available
Phase 2 (Clinical): An in-vivo clinical MRI study.

The same advanced sequences will be added to MRIs performed during routine clinical care: the initial staging MRI before neoadjuvant chemoradiotherapy, the restaging MRI after treatment completion, and follow-up MRIs for patients managed with a non-operative Watch-and-Wait strategy. For each patient, we will collect imaging data, demographics, medical history, tumor characteristics, treatment details, pathology reports, and clinical follow-up (endoscopy and MRI). All data will be pseudonymized. The second phase involves developing a computational model to predict response to neoadjuvant therapy. A machine learning tool will be designed to predict complete pathological response based on quantitative MRI, standard clinical MRI, and clinical information
Altro: questionnaire completion

For all patients, questionnaires will be completed:

  • At the MRI staging if applicable,
  • At the MRI restaging,
  • Every 3 months during the first year; and
  • Every 6 months during the second year.

The following validated questionnaires will be used:

  • EORTC QLQ-C30 (overall quality of life)
  • EORTC QLQ-CR29 (colorectal cancer-specific symptoms)
  • EORTC IN-PATSAT32 (patient satisfaction with care)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
developpement and validation of a methodological framework based on advanced MRI data to predict pathological complete response in patients with locally advanced rectal cancer after neoadjuvant treatment
Lasso di tempo: From the baseline to the end of follow up, assessed up to 27 months

using the area under the ROC curve (AUC) to distinguish pathological complete response (pCR) from residual disease.
From the baseline to the end of follow up, assessed up to 27 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
evaluation of the overall diagnostic performance of the predictive model.
Lasso di tempo: From the baseline to the end of follow up, assessed up to 27 months

The overall diagnostic performance of the model will be evaluated using various indicators: Diagnostic accuracy: defined as the overall proportion of correct classifications, Sensitivity, Specificity, Positive predictive value and Negative predictive value
From the baseline to the end of follow up, assessed up to 27 months
identification and validation of new MRI biomarkers capable of distinguishing residual tumor from benign fibrotic tissue, using ex vivo MRI of surgical specimens with direct correlation to histological data.
Lasso di tempo: From the baseline to the end of follow up, assessed up to 27 months

MRI-histology correlation: statistical correlation between advanced MRI data (derived from ex vivo acquisitions) and the corresponding histological measurements of surgical specimens. Regions of interest (ROIs) defined on ex vivo MRI will be matched with digitized histology. This criterion will validate the new biomarkers.
From the baseline to the end of follow up, assessed up to 27 months
establishment of a rectal MRI database to support this project and future research.
Lasso di tempo: From the baseline to the end of follow up, assessed up to 27 months

Establishment of a data registry: creation of a functional, populated database of rectal cancer cases that is compliant with the FAIR principles (Findable, Accessible, Interoperable, Reusable).
From the baseline to the end of follow up, assessed up to 27 months
assessment of the impact of the disease and therapeutic strategies on patients' quality of life.
Lasso di tempo: From the baseline to the end of follow up, assessed up to 27 months

Quality of life scores: scores obtained from standardized questionnaires collected via a digital application to assess the overall impact of the disease and treatments on patients' lives. These will be analyzed using linear mixed models, comparing the surgical group with the "Watch-and-Wait" group over time.
From the baseline to the end of follow up, assessed up to 27 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigatori

  • Direttore dello studio: Stephanie NOUGARET, PHD, ICM Co. Ltd.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 novembre 2029

Completamento dello studio (Stimato)

1 novembre 2029

Date di iscrizione allo studio

Primo inviato

2 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 febbraio 2026

Primo Inserito (Effettivo)

11 febbraio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PROICM 2025-07 RES

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

Periodo di condivisione IPD

Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.

Criteri di accesso alla condivisione IPD

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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