CancerNCT03262311
Pimo Study: Extracellular Vesicle-based Liquid Biopsy to Detect Hypoxia in Tumours
A study testing Hypoxia marker in people with Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Hypoxia marker
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2017to 12 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
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.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- Hypoxia marker
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia markerOther
Also called Pimonidazole
Single oral dose of pimonidazole 500 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia marker | Experimental | Administration of a single dose of the hypoxia marker Pimonidazole Receives: Other: Hypoxia marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detectable pimonidazole staining
Number of cancer patients with detectable pimonidazole staining in extracellular vesicles isolated from blood samples after a single dose of pimonidazole
Measured: 24 hours and 2 weeks (+/- 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start10 Nov 2017
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Navita Somaiah, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262311
- Sponsor's protocol ID
- CCR4770
- Status last verified
- Dec 2019
- First submitted
- 17 Aug 2017
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pimo Study: Extracellular Vesicle-based Liquid Biopsy to Detect Hypoxia in Tumours
- ClinicalTrials.gov ID
- NCT03262311
- Acronym / sponsor ID
- CCR4770
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoxia marker | Experimental | Other: Hypoxia markerAdministration of a single dose of the hypoxia marker Pimonidazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxia markerAlso: PimonidazoleSingle oral dose of pimonidazole 500 mg/m2 | Other | Hypoxia marker |
Primary outcome
Detectable pimonidazole staining
Time frame: 24 hours and 2 weeks (+/- 5 days)
Number of cancer patients with detectable pimonidazole staining in extracellular vesicles isolated from blood samples after a single dose of pimonidazole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navita Somaiah principal investigator
Institute of Cancer Research, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia marker in people with Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detectable pimonidazole staining (time frame: 24 hours and 2 weeks (+/- 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.