Bladder CancerGemtransNCT01343121
Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy
A study testing sample collection in people with Bladder Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- sample collection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2012to 24 Nov 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed diagnosis of muscle-invasive transitional cell carcinoma.
- suitable for treatment with radical concurrent chemoradiotherapy with GemX.
- Standard radiological assessments with CT or MR for staging.
- ECOG performance status 0-2
- Adequate pre-treatment haematological and biochemical parameters
- Age greater than or equal to 18 years
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- No significant co-morbidity thereby excluding patient from having radical treatment.
- No previous treatment for diagnosis of muscle-invasive bladder cancer or other pelvic radiotherapy.
- Women of child bearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 3 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy
- Patients must have given written informed consent
Who cannot join
- Patients with a known history of anaphylactic reaction to any other drug.
- Patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix
- Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial.
- Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial Any other serious uncontrolled medical conditions
- Clinical evidence of metastatic disease to brain
- Any pregnant or lactating woman
- Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, Gtr Manchester, M20 4BX
About this study
The purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy.
- Conditions
- Bladder Cancer
- Being tested
- sample collection
- Keywords
- Radiotherapy, GemX Chemoradiotherapy, Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample collectionOther
Blood samples will be collected on days 1, 8, 15 and 22. They will be taken 30 minutes and 2 hours post Gemcitabine infusion.
sample collectionOther
Urine will be collected on days 1, 8, 15 and 22. They will be taken pre gemcitabine and 2 hours post Gemcitabine
Sample CollectionOther
Quality of Life (QOL) questionnaires given to the patient at each visit
| Study group | Role | What they receive |
|---|---|---|
| sample collection | Other | This is a single arm study. Patients will be seen on day 1, 8, 15 and 22 and will have the following samples collected:
* Pre gemcitabine urine sample
* Blood sample 30 minutes post Gemcitabine infusion
* Urine and blood sample 2 hours post Gemcitabine infusion Receives: Other: sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does response at Cystoscopy correlate with results of sample analysis
To test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of gemcitabine and its metabolites, 30 mins or 2 hrs post-infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy. Gemcitabine will be measured in plasma by HPLC-MS using a published validated method. We have developed an assay for intracellular gemcitabine triphosphate which should determine levels in PBMCs from 10 - 15 ml blood. Response at Cystoscopy is measured as either complete response, superficial disease or muscle-invasive disease.
Measured: 3 months following the end of GemX chemoradiation
Secondary outcomes (2)
cause-specific and overall survival rates
Measured: 3 years
acute and late toxicities as assessed by RTOG and LENT SOM scales
Toxicity is measured using LENT-SOMA (patient-reported) and CTCAE v4.0 (clinical assessment) during treatment and at follow up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study start2 Feb 2012
- Primary completion24 Nov 2017
- Study completion24 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Ananya Choudhury, Phd, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343121
- Sponsor's protocol ID
- 10_DOG04_124
- Acronym
- Gemtrans
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2011
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy
- ClinicalTrials.gov ID
- NCT01343121
- Acronym / sponsor ID
- Gemtrans / 10_DOG04_124
- Conditions
- Bladder Cancer
- Keywords
- Radiotherapy, GemX Chemoradiotherapy, Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 2 Feb 2012 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 24 Nov 2017 (actual)
- First posted
- 27 Apr 2011 (estimated)
- 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 hypothesis that plasma, peripheral blood mononuclear cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sample collection | Other | Other: sample collectionThis is a single arm study. Patients will be seen on day 1, 8, 15 and 22 and will have the following samples collected: * Pre gemcitabine urine sample * Blood sample 30 minutes post Gemcitabine infusion * Urine and blood sample 2 hours post Gemcitabine infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically confirmed diagnosis of muscle-invasive transitional cell carcinoma.
- suitable for treatment with radical concurrent chemoradiotherapy with GemX.
- Standard radiological assessments with CT or MR for staging.
- ECOG performance status 0-2
- Adequate pre-treatment haematological and biochemical parameters
Key exclusion criteria (7 listed)
- Patients with a known history of anaphylactic reaction to any other drug.
- Patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix
- Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial.
- Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial Any other serious uncontrolled medical conditions
- Clinical evidence of metastatic disease to brain
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 |
|---|---|---|
| sample collectionBlood samples will be collected on days 1, 8, 15 and 22. They will be taken 30 minutes and 2 hours post Gemcitabine infusion. | Other | sample collection |
| sample collectionUrine will be collected on days 1, 8, 15 and 22. They will be taken pre gemcitabine and 2 hours post Gemcitabine | Other | sample collection |
| Sample CollectionQuality of Life (QOL) questionnaires given to the patient at each visit | Other | sample collection |
Primary outcome
Does response at Cystoscopy correlate with results of sample analysis
Time frame: 3 months following the end of GemX chemoradiation
To test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of gemcitabine and its metabolites, 30 mins or 2 hrs post-infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy. Gemcitabine will be measured in plasma by HPLC-MS using a published validated method. We have developed an assay for intracellular gemcitabine triphosphate which should determine levels in PBMCs from 10 - 15 ml blood. Response at Cystoscopy is measured as either complete response, superficial disease or muscle-invasive disease.
2 secondary outcomes
cause-specific and overall survival rates
Time frame: 3 years
acute and late toxicities as assessed by RTOG and LENT SOM scales
Time frame: 3 years
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 13 Aug 2021.
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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.
Ananya Choudhury, Phd principal investigator
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sample collection in people with Bladder Cancer, run by The Christie NHS Foundation Trust 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 10 inclusion and 7 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 13 Aug 2021. 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?
Does response at Cystoscopy correlate with results of sample analysis (time frame: 3 months following the end of GemX chemoradiation). 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 13 Aug 2021.