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A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer

18. juli 2021 oppdatert av: Tianjin Medical University Cancer Institute and Hospital

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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

2000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
      • Tianjin, Kina, 300060
        • Rekruttering
        • Tianjin Medical University Cancer Institute and Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 35 år (Voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

Inclusion Criteria:

  1. Histologically confirmed as breast cancer.
  2. The age of diagnosis was 18-35 years old.
  3. ECOG score was 0-2, and the expected survival time was more than 3 months.
  4. No serious complications; no liver, kidney, hematopoiesis dysfunction.
  5. Informed consent, and patients willing to long-term follow-up. -

Exclusion Criteria:

  1. 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.
  2. Having a clear history of neurological or mental disorders (including epilepsy or dementia).
  3. Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.
  4. Pregnant or lactating female patients.
  5. HIV infected patients.
  6. Patients with other tumors.
  7. After comprehensive evaluation, the researchers believe that patients are not suitable for this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PFS
Tidsramme: 5 years
The time from the first medication at the beginning of treatment to the first disease progression or death from any cause
5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
OS
Tidsramme: 5 years
time from randomization to death from any cause
5 years
ORR
Tidsramme: 5 years
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)
5 years

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AEs
Tidsramme: 5 years
It refers to any adverse medical event during the clinical study. It is not necessarily a causal relationship with treatment.
5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2020

Primær fullføring (Forventet)

31. mars 2023

Studiet fullført (Forventet)

31. mars 2025

Datoer for studieregistrering

Først innsendt

26. februar 2021

Først innsendt som oppfylte QC-kriteriene

18. juli 2021

Først lagt ut (Faktiske)

21. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juli 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YWBC-001

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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Sponsorer og samarbeidspartnere

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Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

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Sponsor / samarbeidspartnere

Steder

3
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