Condition category
Cancer
Date applied
10/10/2012
Date assigned
11/10/2012
Last edited
11/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
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

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.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13125

Ethics approval

London City and East NRES, 02 August /2012 ref: 12/LO/1123

Study design

Non-randomised interventional trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below 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

Clinical Oncology Department
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

http://www.guysandstthomas.nhs.uk/

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

Publication citations

Additional files

Editorial Notes