- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03314870
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer (Breast-sign)
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Brussels, Belgien, 1200
- Rekruttering
- Cliniques Universitaires Saint-luc
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Kontakt:
- François DUHOUX, MD,PhD
- Telefonnummer: 0032 2 764
- E-mail: francois.duhoux@uclouvain.be
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Women and men with breast cancer
- Treated with neoadjuvant chemotherapy
Exclusion Criteria:
- None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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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Andet: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: an average of 2 years
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an average of 2 years
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: François DUHOUX, MD, PhD, francois.duhoux@uclouvain.be
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017/25JUL/376
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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