A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer
A Observational RWS of YWBC on the Prognosis and Treatment
This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients.
We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The study can only be formally carried out with the written approval of the ethics committee. We regularly submit annual research reports to the ethics committee. We will inform the ethics committee in writing when the study is discontinued and / or completed.
All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation.
In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Tianjin, Chine, 300060
- Recrutement
- Tianjin Medical University Cancer Institute and Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
We expect to enroll 2000 young breast cancer patients (18-35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel).
Subgroups were stratified according to different stages, treatment methods and pathological types.
The gene mutation characteristics, treatment sensitive genes and prognosis gene spectrum of different groups and subgroups were studied.
La description
Inclusion Criteria:
- Histologically confirmed as breast cancer.
- The age of diagnosis was 18-35 years old.
- ECOG score was 0-2, and the expected survival time was more than 3 months.
- No serious complications; no liver, kidney, hematopoiesis dysfunction.
- Informed consent, and patients willing to long-term follow-up. -
Exclusion Criteria:
- 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study.
- Having a clear history of neurological or mental disorders (including epilepsy or dementia).
- Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.
- Pregnant or lactating female patients.
- HIV infected patients.
- Patients with other tumors.
- After comprehensive evaluation, the researchers believe that patients are not suitable for this study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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PFS
Délai: 5 years
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The time from the first medication at the beginning of treatment to the first disease progression or death from any cause
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5 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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OS
Délai: 5 years
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time from randomization to death from any cause
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5 years
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ORR
Délai: 5 years
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After treatment, the percentage of patients whose tumor volume reduced to a predetermined value and could maintain the minimum time limit was evaluated, including complete remission (CR) + partial remission (PR)
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5 years
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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AEs
Délai: 5 years
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It refers to any adverse medical event during the clinical study.
It is not necessarily a causal relationship with treatment.
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5 years
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- YWBC-001
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur Cancer du sein
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AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie