Clinical trial · Interventional
Pimo Study: Extracellular Vesicle-based Liquid Biopsy to Detect Hypoxia in Tumours
NCT03262311CI-TRIAL-00042453completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test the potential of a relatively simple serum assay that aims to identify patient subpopulations whose curative radiotherapy outcome is likely to be compromised by radiobiological tumour hypoxia (prognostic value) and who are most likely to gain (predictive value) from the addition of radiation sensitiser drugs or targeted radiotherapy dose escalation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypoxia marker | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypoxia marker
- description
- Administration of a single dose of the hypoxia marker Pimonidazole
- interventionNames
- Other: Hypoxia marker
Primary outcomes (1)
- measure
- Detectable pimonidazole staining
- timeFrame
- 24 hours and 2 weeks (+/- 5 days)
- description
- Number of cancer patients with detectable pimonidazole staining in extracellular vesicles isolated from blood samples after a single dose of pimonidazole
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.