LymphomaBioACTNCT01921998
Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy
An observational study of Lymphoma and Sarcoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Biomarker and health economics
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Nov 2015
- Phase
- Observational
- 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
Study population: Patients with Lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%.
Who may be able to join
- Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin [Aapro et al, 2011a].
- Age 18 or older
- Performance Status 0-2
- Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
Who cannot join
- Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
- Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
- Radio-immunotherapy within the last 8 weeks.
- Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) [Gonzalez-Quintela et al, 2009, Lavallard et al, 2011]
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.
This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.
- Being tested
- Biomarker and health economics
- Medical subject headings
- Lymphoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker and health economicsProcedure or surgery
Biomarkers CK18 and FLT3 Ligand will be collected
| Study group | Role | What they receive |
|---|---|---|
| Biomarker and health economics | Biomarkers will be taken throughout cycle 1. Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use. Receives: Procedure: Biomarker and health economics |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
to confirm in a prospective cohort whether changes in CK18 and FLT3 ligand at day 3 of chemotherapy can identify patients at risk of subsequent severe chemotherapy toxicity
Measured: day 3
Secondary outcomes (6)
number of hospital admissions for febrile neutropenia
Measured: end of chemotherapy at approximately 6 months
Total number of overnight stays or stays in A&E of over 4 hours spent in hospital
Measured: End of study chemotherapy at approximately 6 months
Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy
Measured: End of chemotherapy at approximately 6 months
Number of total days delay in receiving chemotherapy treatment compared to planned delivery
Measured: end of chemotherapy at approximately 6 months
Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires
Measured: cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors
Measured: end of study chemotherapy at approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015 (estimated)
Why it stopped: Trial has been suspended due to lack of resource and staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Robinson, The Christie NHS Foundation Trust
- Investigators
- Alastair Greystoke, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921998
- Sponsor's protocol ID
- 11_DOG05_99
- Acronym
- BioACT
- Status last verified
- Feb 2015
- First submitted
- 9 Aug 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy
- ClinicalTrials.gov ID
- NCT01921998
- Acronym / sponsor ID
- BioACT / 11_DOG05_99
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Trial has been suspended due to lack of resource and staff
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (estimated)
- First posted
- 14 Aug 2013 (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.
Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.
This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker and health economics | – | Procedure: Biomarker and health economicsBiomarkers will be taken throughout cycle 1. Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%.
Key inclusion criteria (4 listed)
- Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin [Aapro et al, 2011a].
- Age 18 or older
- Performance Status 0-2
- Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
Key exclusion criteria (5 listed)
- Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
- Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
- Radio-immunotherapy within the last 8 weeks.
- Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) [Gonzalez-Quintela et al, 2009, Lavallard et al, 2011]
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
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 |
|---|---|---|
| Biomarker and health economicsBiomarkers CK18 and FLT3 Ligand will be collected | Procedure or surgery | Biomarker and health economics |
Primary outcome
sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
Time frame: day 3
to confirm in a prospective cohort whether changes in CK18 and FLT3 ligand at day 3 of chemotherapy can identify patients at risk of subsequent severe chemotherapy toxicity
6 secondary outcomes
number of hospital admissions for febrile neutropenia
Time frame: end of chemotherapy at approximately 6 months
Total number of overnight stays or stays in A&E of over 4 hours spent in hospital
Time frame: End of study chemotherapy at approximately 6 months
Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy
Time frame: End of chemotherapy at approximately 6 months
Number of total days delay in receiving chemotherapy treatment compared to planned delivery
Time frame: end of chemotherapy at approximately 6 months
Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires
Time frame: cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors
Time frame: end of study chemotherapy at approximately 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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.
Alastair Greystoke study chair
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?
An observational study of Lymphoma and Sarcoma, 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 4 inclusion and 5 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: paused, as of the sponsor's last update on 4 Feb 2015. 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?
Results are not available in the source record.
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?
sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity (time frame: day 3). 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 4 Feb 2015.