- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02126800
Rapid Medical Donation Programme for Breast Cancer (LEGACY)
Rapid Medical Donation Programme for Breast Cancer to Examine Tumour Heterogeneity
Treatment of breast cancer has traditionally been based on the primary tumour's features in the breast. Only recently, when cancer returns at other sites, has there been an attempt to biopsy the metastatic disease and change treatments accordingly. A 'repeat biopsy' can be technically difficult, painful and, when possible, only represents a small sample of one of many metastases.
Even when one deposit responds to a new treatment, a neighbouring one may continue to grow. There is an urgent need to characterise all deposits, particularly the lethal ones which progress despite all treatments.
This study will enable the comprehensive analysis of the metastatic process and the evolution of the breast cancer through the course of its treatment. Patients who have consented during life to donate their tissues for molecular analysis will provide the means for such an analysis.
Main aims:
- To comprehensively and systematically examine metastatic breast cancer by its detailed exploratory molecular characterization to elucidate the possible inter- and intratumoural heterogeneity between the primary tumour and the majority of metastatic sites.
- To map the natural history of the metastatic breast cancer process
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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London, Storbritannia, SW3 6JJ
- Rekruttering
- Royal Marsden NHS Foundation Trust
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Ta kontakt med:
- Sally Bennett, RN
- Telefonnummer: +44 (0)20 7153 5004
- E-post: LEGACY-BC@icr.ac.uk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients who have completed active treatment (or trials) for metastatic breast cancer.
- Patients referred to either community or the hospital-based palliative care unit from Royal Marsden National Health Service Foundation Trust.
Exclusion Criteria:
- Lack of capacity / inability to give informed consent.
- Diagnosis of alternative cancer within the last 5 years other than resected basal cell skin cancer or cervical intraepithelial neoplasia.
- Patients known to be HIV, Hepatitis B virus or Hepatitis C virus positive on serology .
- Spongiform encephalopathy (known or suspected CJD) .
- Eligibility for or current participation in a clinical trial (excluding palliative care trials)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The acquisition of tumour tissue from multiple metastatic sites.
Tidsramme: Within 6 hours from the time of death.
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Within 6 hours from the time of death.
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Peter A Barry, MB BS, Royal Marsden NHS Foundation Trust
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CCR3995
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