Evaluation of hypoxia using genetic and imaging biomarker in head and neck squamous cell carcinoma
| ISRCTN | ISRCTN49555010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49555010 |
| Secondary identifying numbers | 13125 |
- Submission date
- 10/10/2012
- Registration date
- 11/10/2012
- Last edited
- 16/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Yae-eun Suh
Scientific
Scientific
Clinical Oncology Department
Ground floor Lambeth Wing
St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
| yae-eun.suh@kcl.ac.uk |
Study information
| Study design | Non-randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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) |
| Study acronym | BoHEMIaN |
| Study objectives | 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(s) | London City and East NRES, 02/08/2012, ref: 12/LO/1123 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Characterisation and correlation of molecular and imaging biomarkers of hypoxia |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 14/10/2012 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 14/10/2012 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Thomas Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Cranofacial Dental Floor 28
London
SE1 9RT
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
University/education
King's College London Health Partners (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/01/2017: No publications found, verifying study status with principal investigator.
