Pimo Study: Extracellular Vesicle-based Liquid Biopsy to Detect Hypoxia in Tumours
Panoramica dello studio
Descrizione dettagliata
Aim: To analyse tiny cancer cell fragments called extracellular vesicles isolated from blood samples for their ability to identify patients with tumours that are relatively oxygen-starved and expected to be resistant to ionising radiation and many chemotherapy drugs.
Participants: 16 patients with proven cancer plus 4 healthy volunteers who give written informed consent to participate will be included in the study.
Recruitment: Eligible patients will be identified in the Outpatient Department at The Royal Marsden in Sutton or London and given a copy of the Information Sheet describing the study in detail. Dr Somaiah's team will call these potential volunteers at least 24 hours after they have received written information about the study to answer any questions. The same consent process will be followed for staff members who agree to participate as healthy volunteers. Research subjects who offer verbal agreement to participate will be asked for written consent and will be allocated a study ID. This will be used on all trial documentation and blood samples together with their initials and date of data/sample collection.
Pimonidazole administration: This well-established drug has the valuable property of binding exclusively to oxygen- starved tissues in a form that can be detected as a colour change in cell fragments released into the blood stream. A single oral dose of pimonidazole 500 mg/m2 will be prescribed and administered in a Royal Marsden outpatient clinic after confirmation of eligibility and completion of written informed consent. A member of the research team will monitor subjects to ensure that the prescribed drug is successfully taken (swallowed with water) before leaving the hospital (or going back to work/home in the case of healthy volunteers).
Blood sample: A peripheral venous blood sample of 20 ml will be collected from each participant the day after administration of pimonidazole, since it takes several hours for the drug to be absorbed and to bind to proteins and other molecules in oxygen-starved cells. A second sample will be collected 14 ±5 days later in order to confirm that all coloured cell fragments have disappeared from the circulation.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Surrey
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Sutton, Surrey, Regno Unito, SM2 5PT
- The Royal Marsden NHS Foundation Trust
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Patients i) Age ≥18 years ii) Biopsy-proven invasive carcinomas of head and neck, lung, bladder, uterine cervix or breast iii) Bulky (≥4 cm or ≥ 30 cc) primary/locally recurrent tumour or regional node masses iv) No clinical evidence of distant metastases unless oligometastases (ie distant relapse in only a limited number of regions for which local ablative therapy could be curative) v) Patient due for surgery, radiotherapy, systemic therapy or no anti-cancer treatment vi) Written informed consent
Healthy volunteers i) Age ≥18 years ii) Written informed consent
Exclusion Criteria:
Patients i) Inadequate cognitive ability to undertake the appropriate informed consent procedure
Healthy volunteers i) Past history of cancer, apart from non-melanomatous skin cancer or in situ carcinoma uterine cervix
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Hypoxia marker
Administration of a single dose of the hypoxia marker Pimonidazole
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Single oral dose of pimonidazole 500 mg/m2
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Detectable pimonidazole staining
Lasso di tempo: 24 hours and 2 weeks (+/- 5 days)
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Number of cancer patients with detectable pimonidazole staining in extracellular vesicles isolated from blood samples after a single dose of pimonidazole
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24 hours and 2 weeks (+/- 5 days)
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Navita Somaiah, Institute of Cancer Research, United Kingdom
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CCR4770
Informazioni su farmaci e dispositivi, documenti di studio
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