Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients
AI predicts breast cancer treatment response in early-stage patients.
Plain English Summary
Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients is a Not Applicable clinical trial sponsored by Institut Cancerologie de l'Ouest studying Breast Cancer. This study tests if artificial intelligence (AI) can predict how well early breast cancer patients will respond to chemotherapy before treatment starts. It is for women and men diagnosed with early-stage breast cancer who need chemotherapy before surgery. Participants will provide consent, undergo a biopsy and blood draws, and complete questionnaires. Their medical data will be collected over time. Currently, treatment response is mainly assessed after chemotherapy. This study aims to predict it earlier. The trial aims to enroll 300 participants.
Official Summary
Breast cancer (BC) is the most common cancer in women in France with nearly 58,500 new cases and 12,150 deaths estimated in 2018 . Two major achievements have been made in the last five years for breast cancer patients. The first is therapeutic with the approval of immune checkpoint inhibitors in advanced and early triple-negative BC (TNBC) and the impressive efficacy of new antibody-drug conjugated in all BC subtypes. The second is conceptual with the generalization of adaptive therapeutic strategies guided by pathological responses after neoadjuvant therapy in early TNBC, HER2+, HR+ and BRCA mutated breast cancer. This new paradigm in the treatment of cancer patients completely redefined prognostic factors that were previously established with conventional approaches Pathological response remains a major prognostic factor especially for TNBC and HER2 early breast cancer. However, this parameter is evaluated at the end of neoadjuvant treatment and for patients with residual disease, the prognosis remains poor despite some adaptative strategies. Our project is to integrate massive and heterogeneous data concerning the disease (clinical and biological data, imaging and histological results (with multi-omics data)) and patient's environment, personal and familial history. These data are multiple and have dynamic interactions overtime. With the help of mathematical units with biological competences and scientific collaborations, our project is to improve the prediction of treatment response, based on clinical and molecular heterogeneous big data investigation. The main objective of this project is to set up a clinicobiological database prospectively by collecting prospective clinical, biological, pathological and multi-omic data from 300 Patients with early BC treated at the ICO in order to define an algorithm of individual decision for the prediction of the response to this treatment.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have confirmed early-stage breast cancer, and require chemotherapy before surgery. You cannot join if you have other cancers treated in the last 5 years (except certain types), non-epithelial breast cancer, or conditions preventing biopsies. Pregnant or nursing individuals cannot participate. You must be able to attend all study visits and follow-up appointments. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how accurately the AI can predict a complete response to chemotherapy, meaning no cancer is found after treatment, which is a key indicator of long-term success. The specific primary outcome measures are: The accurancy predictive parameters for complete pathological response (pCR) after neoadjuvant chemotherapy (6 months after the initiation of neoadjuvant chemotherapy); To determine the rate of Event Free Survival (5 years after the initiation of treatment); To determine the rate of Overall Survival (5 years after the initiation of treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to develop an AI tool to predict treatment response, potentially leading to more personalized and effective treatment strategies for early breast cancer. This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial explores the use of AI in oncology, a rapidly growing field. Success could lead to new diagnostic tools, potentially impacting the market for predictive diagnostics in cancer care.
Is This Trial Right for Me?
Ask your doctor if this study is a good fit for you and how the biopsy and blood draws will be done. Be prepared to attend regular appointments for data collection and follow-up throughout your treatment and for several years after. Understand that your personal health and lifestyle information will be collected to help train the AI model. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 300 participants
Interventions
- PROCEDURE: Biopsy — biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment
- PROCEDURE: Blood samples — Centralized blood samples will be performed at inclusion + evaluation visits
- BEHAVIORAL: Questionnaires — Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion
Primary Outcomes
- The accurancy predictive parameters for complete pathological response (pCR) after neoadjuvant chemotherapy (6 months after the initiation of neoadjuvant chemotherapy)
- To determine the rate of Event Free Survival (5 years after the initiation of treatment)
- To determine the rate of Overall Survival (5 years after the initiation of treatment)
Full Eligibility Criteria
Inclusion Criteria: 1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening biopsy, blood samples and questionnaires 2. 18 years old or at time of written consent 3. Patient with histologically confirmed breast cancer 4. Absence of metastatic disease 5. Patient requiring neoadjuvant chemotherapy 6. Performance status ≤ 2 (according to WHO criteria) 7. Indication of any systemic therapeutic strategy can be performed alongside this current cohort in accordance with national and / or international recommendations. 8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 9. Patient must be affiliated to a Social Health Insurance 10. For patients taking part in the RTW WP: working patients at time of diagnostic and in sick leave at time of inclusion Exclusion Criteria: 1. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or in situ carcinoma of the cervix) 2. Non epithelial breast cancer 3. Coagulopathy or other pathology that contraindicates biopsy procedures 4. Pregnant or nursing patient 5. Individual deprived of liberty or placed under the authority of a tutor 6. Impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons 7. For patients taking part in the RTW WP: patient in an "self employed" or "interim" employment situation 8. For patients taking part in the RTW WP: Patients working part-timeProcedures for withdrawal of incorrectly enrolled patients are presented in Section 7.5.
Trial Locations
- Institut de Cancérologie de l'Ouest, Angers, France
- Institut de Cancérologie de l'Ouest, Saint-Herblain, France
Frequently Asked Questions
What is clinical trial NCT05981326?
NCT05981326 is a Not Applicable INTERVENTIONAL study titled "Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients." It is currently recruiting and is sponsored by Institut Cancerologie de l'Ouest. The trial targets enrollment of 300 participants.
What conditions does NCT05981326 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT05981326?
The interventions being studied include: Biopsy (PROCEDURE), Blood samples (PROCEDURE), Questionnaires (BEHAVIORAL). biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment
What does Not Applicable mean for NCT05981326?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05981326?
This trial is currently "Recruiting." It started on 2023-10-31. The estimated completion date is 2033-04.
Who is sponsoring NCT05981326?
NCT05981326 is sponsored by Institut Cancerologie de l'Ouest. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05981326?
The trial aims to enroll 300 participants. The trial is currently recruiting and accepting new participants.
How is NCT05981326 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05981326?
The primary outcome measures are: The accurancy predictive parameters for complete pathological response (pCR) after neoadjuvant chemotherapy (6 months after the initiation of neoadjuvant chemotherapy); To determine the rate of Event Free Survival (5 years after the initiation of treatment); To determine the rate of Overall Survival (5 years after the initiation of treatment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05981326 being conducted?
This trial is being conducted at 2 sites, including Angers; Saint-Herblain (France).
Where can I find official information about NCT05981326?
The official record for NCT05981326 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05981326. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05981326 testing in simple terms?
This study tests if artificial intelligence (AI) can predict how well early breast cancer patients will respond to chemotherapy before treatment starts. It is for women and men diagnosed with early-stage breast cancer who need chemotherapy before surgery.
Why is this trial significant?
This trial matters because it aims to develop an AI tool to predict treatment response, potentially leading to more personalized and effective treatment strategies for early breast cancer.
What are the potential risks of participating in NCT05981326?
The main risks involve the biopsy procedure, which can cause pain, bleeding, or infection. Blood draws may cause bruising or discomfort. There's a small risk of data privacy breaches, although measures are in place to protect your information. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05981326?
Ask your doctor if this study is a good fit for you and how the biopsy and blood draws will be done. Be prepared to attend regular appointments for data collection and follow-up throughout your treatment and for several years after. Understand that your personal health and lifestyle information will be collected to help train the AI model. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05981326 signal from an investment perspective?
This trial explores the use of AI in oncology, a rapidly growing field. Success could lead to new diagnostic tools, potentially impacting the market for predictive diagnostics in cancer care. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will provide consent, undergo a biopsy and blood draws, and complete questionnaires. Their medical data will be collected over time. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.