- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03314870
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer (Breast-sign)
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast
Studieöversikt
Detaljerad beskrivning
Breast cancer is the most frequent cancer in women. It is often treated with neoadjuvant chemotherapy, administered before surgical resection. Unfortunately, many patients do not respond to this treatment, or only respond partially. Clinicians therefore need predictive biomarkers of treatment response. Thanks to an innovative technique, called CATS, this study aims at identifying blood and tissue biomarkers which are predictive of response to chemotherapy.
The objective of this study is to develop molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition (EMT) status and their immune status. As these two parameters are known to be responsible for incomplete responses to chemotherapy, investigators hypothesize that these signatures will be predictive of response to neoadjuvant chemotherapy. In a second step, researchers will evaluate the ability of these signatures to predict treatment response in breast cancer patients treated with neoadjuvant chemotherapy.
The investigators will investigate two types of signatures: a tissue signature and a circulating signature. The former is based on the level of expression of several mRNA and miRNA assessed by CATS-RNASeq in the biopsy. The circulating signature will be based on the expression level of several miRNA by the same technique. Given that the expression level of tumoral miRNA is affected by the EMT and immunological status, and given that tumors secrete miRNA in the circulation, investigators expect the miRNA plasma content to reflect the EMT and immunological status of the tumor. The circulating signature will have the additional advantage of being independent of tumor heterogeneity.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Brussels, Belgien, 1200
- Rekrytering
- Cliniques Universitaires Saint-Luc
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Kontakt:
- François DUHOUX, MD,PhD
- Telefonnummer: 0032 2 764
- E-post: francois.duhoux@uclouvain.be
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Women and men with breast cancer
- Treated with neoadjuvant chemotherapy
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: Retrospective study
Tumoral tissue of 100 patients with breast cancer treated with neoadjuvant chemotherapy.
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To identify molecular signatures of EMT / immune status by using the random forest algorithm.
The best signature will be measured by RT-qPCR and/or CATS-RNASeq technics.
|
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Övrig: Prospective study
Tumoral tissue and plasma of 120 patients with breast cancer treated with neoadjuvant chemotherapy.
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To identify molecular signatures of EMT / immune status by using the random forest algorithm.
The best signature will be measured by RT-qPCR and/or CATS-RNASeq technics.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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The number of molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition status and their immune status.
Tidsram: an average of 2 years
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an average of 2 years
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Samarbetspartners och utredare
Utredare
- Huvudutredare: François DUHOUX, MD, PhD, francois.duhoux@uclouvain.be
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2017/25JUL/376
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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