DIAPHRAGM: Diagnostic and prognostic biomarkers in the rational assessment ... | Not Recruiting
DIAPHRAGM: Diagnostic and prognosti... | Not Recruiting
DIAPHRAGM: Diagnostic and prognostic biomarkers in the rational assessment of mesothelioma
DIAPHRAGM

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Medical Conditions
  • Suspected pleural malignancy or documented history of asbestos exposure
Primary Contact Details
Dr Kevin Blyth
+44 (0)141 232 4026
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN10079972
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-blood-tests-diagnose-mesothelioma-diaphragm
Research Details
  • Novel biomarkers are urgently required for the diagnosis, prognostication and monitoring of MPM. An ideal MPM biomarker would be measurable in blood, have sufficient sensitivity and specificity for MPM to improve diagnostic accuracy in patients presenting with a pleural effusion, provide useful prognostic/monitoring information in patients with confirmed MPM and clinicians would have a clear understanding of the biological basis of the information provided.

    We hypothesise that SOMAscan and/or Fibulin-3 will provide clinically useful diagnostic/prognostic information regarding MPM when these biomarkers are measured in blood, in patients presenting with suspected pleural malignancy.

    The primary aim is to determine whether levels of SOMAscan and/or Fibulin-3 in blood at presentation can differentiate MPM from asbestos-exposed controls and patients with other causes of pleural effusion with sufficient degree of sensitivity and specificity to be of routine clinical value.

    Secondary aims are:
    1. Determine whether levels of SOMAscan and/or Fibulin-3 at presentation provide clinically useful prognostic information in MPM patients
    2. Determine whether early changes in SOMAscan and/or Fibulin-3 levels after diagnosis (defined by a change in levels at 3 months) are associated with a poorer prognosis in MPM.

    Exploratory Aims:
    1. Determine whether there is any correlation between SOMAscan and/or Fibulin-3 levels in blood and tumour volume, defined by contrast-enhanced Magnetic Resonance Imaging
    2. Determine whether there is any correlation between SOMAscan and/or Fibulin-3 levels in blood and tumour angiogenesis (defined by redistribution rate constant (Kep) and elimination rate constant (Kel)) on contrast-enhanced magnetic resonance (MR) imaging
    3. Determine whether there is any correlation between SOMAscan and/or Fibulin-3 levels in blood and pleural fluid at presentation in patients with MPM
    4. Determine whether SOMAscan and/or Fibulin-3 levels are affected by pleural fluid drainage and pleurodesis at the time of diagnosis
Phase
Not Applicable
Study Design
Prospective multi-centre observational study incorporating a nested cross-sectional sub-study
Study Type
Observational
Intervention

Patients with suspected pleural malignancy:
Visit 1 (Day 0, first clinic visit or in patient stay at hospital)
Core Study Activity:
1. Asbestos exposure history
2. Review eligibility criteria
3. Introduce to study if eligibility criteria met
4. Provide with Core Study Patient Information Sheet (at clinic or via post)

Visit 2 (Day 3)
Core Study Activity:
1. Opportunity for discussion regarding study
2. Sign core study consent form
3. Register patient with Clinical Trials Unit
4. ECOG Performance Status
5. Blood draw for biomarkers with appropriate processing and storage
6. Asbestos exposure history (if not previously performed)
7. Record baseline prognostic indicators, including haemoglobin, leucocyte and platelet counts, lactate dehydrogenase, c-reactive protein and albumin

Visit 3 (Day 9)
Core Study Activity:
1. If a diagnosis of MPM is made - enter follow-up
2. If any non-MPM diagnosis made - exit study

MRI sub-study activity
If no diagnosis is made - consider MRI sub-study (only in WOS patients)
1. Review sub-study eligibility criteria
2. Introduce sub-study if eligible
3. Provide with separate sub-study PIS
4. MRI Safety Questionnaire
5. X-ray orbits if any history of eye injury and retained metallic foreign body

Visit 3a (Day 11-18)

Core Study Activity: None

MRI sub-study activity
1. Opportunity for further discussion with CRF
2. MRI Safety Questionnaire (if not previously recorded)
3. Sign sub-study Consent From
4. Register subject with CTU
5. Pleural MRI scan

Visit 4 (Day 14-21)

Core Study Activity:
• No activity

MRI sub-study activity
Paired Blood and Pleural Fluid Draw for biomarkers with appropriate processing and storage

Visit 5 (day 23-31)
Core Study Activity:
1. If diagnosis of MPM made - enter follow-up
2. If non-MPM diagnosis made - exit study

MRI sub-study activity: None

Visit 6 (Day 62)
Core Study Activity:
Blood draw for SOMAscan and Fibulin-3

MRI sub-study activity: None

Visit 7 (Day 123)
Core Study Activity:
Blood draw for SOMAscan and Fibulin-3

MRI sub-study activity: None

Follow Up Assessment
Core Study Activity:
Two monthly follow up assessments to be performed to determine survival status and any cancer treatments delivered

Intervention Type
Other
Primary Outcome Measures
    1. SOMAscan and Fibulin-3 in blood at presentation
    2. Final diagnosis reached
Secondary Outcome Measures
    1. SOMAscan and Fibulin-3 levels at presentation and at 3 months
    2. Survival

    Exploratory Research Outcomes
    1. Correlation between SOMAscan and/or Fibulin-3 levels and tumour volume, defined by planimetry at contrast-enhanced Magnetic Resonance Imaging
    2. Correlation between SOMAscan and/or Fibulin-3 levels and tumour angiogenesis, Redistribution rate constant (Kep) and elimination rate constant (Kel)) on contrast-enhanced magnetic resonance (MR) imaging
    3. SOMAscan and Fibulin-3 in paired blood and pleural fluid samples
    4. SOMAscan and Fibulin-3 levels at presentation and at 1 month post-biopsy and pleurodesis
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
709 in total: 600 participants with Suspected Pleural Malignancy and 109 participants with asbestos expsure
Participant Inclusion Criteria
    Cases of suspected pleural malignancy:
    1. Informed written consent
    2. Suspected pleural malignancy, as defined by a unilateral pleural effusion or pleural-based mass lesion
    3. Sufficient fitness for diagnostic sampling, including diagnostic pleural aspiration as a minimum
    4. Aged over 18

    Patients with suspected pleural malignancy recruited to the cross-sectional sub-study will be subject to the following additional inclusion criteria:
    1. Recruited in a WoS centre (Southern General, Gartnavel General, Glasgow Royal)
    2. Thoracoscopy indicated to investigate suspected pleural malignancy (defined by negative pleural cytology and non-specific CT findings)
    3. Aged over 18

    Asbestos-exposed subjects:
    1. Documented history of asbestos exposure and associated pleural plaques, asbestosis or diffuse pleural thickening
    2. Informed written consent
    3. Willing and able to travel to a research clinic interview in Glasgow
    4. Aged over 18
Participant Exclusion Criteria
    Cases of suspected pleural malignancy:
    1. Insufficient fitness (based on the site investigatorÂ’s clinical judgement) for diagnostic sampling, including diagnostic pleural aspiration as a minimum

    Patients with suspected Pleural Malignancy recruited to the cross-sectional sub-study will be subject to the following additional exclusion criteria:
    1. Claustrophobia
    2. Pregnancy
    3. Unable to undergo MR imaging due to known contraindications (e.g. pacemaker, ferrous metal implants or foreign body)
    4. Allergy to Gadolinium contrast
    5. Renal impairment (eGFR <30ml/min)

    Asbestos-exposed subjects:
    1. Known MPM
    2. Known pleural effusion of any cause
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Southern General Hospital
Glasgow
Scotland
G51 4TF
Trial Contact(s)
Primary Trial Contact
Dr Kevin Blyth
+44 (0)141 232 4026
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Ireland, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
DIAPHRAGM study: to prospectively assess whether the levels of two novel biomarkers (SOMAscan and Fibulin-3) in blood, can distinguish between malignant pleural mesothelioma (MPM), other malignant pleural effusions and from people who have had previous exposure to asbestos but have no evidence of MPM
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Chief Scientist Office (UK) Ref: ETM/285
Other Study ID Numbers
DIAPHRAGM-2013
Sponsor(s)
NHS Greater Glasgow and Clyde (UK)
Key Dates

Recruitment Start Date

01 Nov 2013

Recruitment End Date

31 Oct 2016

Trial Start Date

01 Nov 2013

Trial End Date

31 Oct 2016

Date added to source

17 Oct 2013

Date updated in source

11 Jul 2014