Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Yae-eun Suh
ORCID ID
Contact details
Clinical Oncology Department
Ground floor Lambeth Wing
St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
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yae-eun.suh@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13125
Study information
Scientific title
Biomarkers of hypoxia evaluation with molecular and 64copper (II) diacetylbis (N4)methylthiosemicarbazone (CuATSM) positron emission tomography/computed tomography (PET/CT) imaging techniques in head and neck squamous cell carcinomas (BoHEMIaN study)
Acronym
BoHEMIaN
Study hypothesis
Hypoxia has long been identified as an important prognostic factor in head and neck cancer. It is associated with poorer loco-regional control and survival in patients treated with radiotherapy. Despite many interventional studies targeting hypoxia, the inability to prospectively identify high risk patients continues to make efforts to overcome hypoxia inefficient, as well as exposing low risk patients to unnecessary treatment toxicity. Current methods being investigated to identify hypoxia from an early stage include the use of molecular and imaging biomarkers of hypoxia. This study will look at exisitng and novel molecular biomarkers from diagnostic biopsy samples and correlate these with the Cu-ATSM PET/CT derived hypoxia score. The aim is to identify a hypoxic molecular signature which will allow the selection of patients who will benefit from hypoxia imaging, with subsequent tailoring of their treatment.
Ethics approval
London City and East NRES, 02/08/2012, ref: 12/LO/1123
Study design
Non-randomised interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Head and neck cancer
Intervention
Tissue samples will be obtained from the Head and Neck Tissue and Data Bank. Immunohistochemistry, expression profiling and miRNA screening to investigate markers of hypoxia will be performed. Copper-ATSM PET images will be interpreted using tumour/muscle ratio and standardised uptake values, and patients will be grouped into tumours with a high or low hypoxia index. Previously defined gene/miRNA expression signatures will be tested for association with the Copper-ATSM derived hypoxia score, immunohistochemical markers and 3 month treatment response. Supervised analyses for discovery of differential gene expression and miRNA expression between high/low hypoxia index tumours will be performed.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Characterisation and correlation of molecular and imaging biomarkers of hypoxia
Secondary outcome measures
No secondary outcome measures
Overall trial start date
14/10/2012
Overall trial end date
31/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with stage III-IV histologically proven HPV negative oropharyngeal squamous cell carcinoma to be treated with radical concomitant chemotherapy and radiotherapy
2. Patients have consented to their original biospy being stored in the tissue bank at GSTFT
3. Age > 18 years
4. ECOG Performance Status </= 2
5. Life expectancy > 12 weeks
6. Adequate organ function and absence of other major concomitant illness, allowing the patient to tolerate the delivery of the radiotracer
7. Patients must be able to provide written and voluntary informed consent
8. All women of childbearing age must have a negative serum or urine pregnancy test documented within 72 hours prior to study enrollment
9. Male and female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 40
Participant exclusion criteria
1. Patients with impaired renal function (serum creatinine > 200)
2. Patients with severely impaired liver function
3. Serious intercurrent conditions or other nonmalignant illnesses that are uncontrolled or whose control may be affected by participation in this study
4. Any patient who has urinary or faecal incontinence
5. Previous history of cancer other than skin basal cell carcinoma
6. ECOG Performance Status >/= 3
7. Pregnant or breastfeeding women
Recruitment start date
14/10/2012
Recruitment end date
31/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust (UK)
Sponsor details
Cranofacial Dental Floor 28
London
SE1 9RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
King's College London Health Partners (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary