Pleural EffusionSPECTRANCT04533854
Investigating Signal Change in Malignant and Non-malignant Pleural Effusions and asCitic Fluid Using fTiR Analysis
An observational study of Pleural Effusion and Ascites, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Lung cancer is a common cancer, associated with a high mortality rate. Pleural effusions are common in lung cancer, developing in up to 40% of patients. Ascites is common in patients with abdominal malignancies and can be the presenting feature in up to 50% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Ascites
- How many people
- 137 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Mar 2021to 26 Sep 2023
- 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
- Adult, Older adult
Study population: Participants with pleural effusions or ascites will be recruited from outpatient clinics, day units within the hospital and from inpatient wards. Only participants already having a diagnostic or therapeutic procedure as part of their standard medical care will be invited to take part.
Who may be able to join
- Aged ≥18 years.
- A confirmed, clinician made diagnosis of the following (supported by standard accepted diagnostic criteria):
- Malignant pleural effusion: confirmed cancer
- lung cancer
- mesothelioma
- or metastatic cancer
Show all 10Show fewer
- Non-malignant pleural effusion: effusion confirmed to be caused by alternative diagnosis
- Malignant ascites: confirmed cancer
- Non-malignant ascites: ascites confirmed to be caused by alternative diagnosis
- Willing and able to give informed consent for participation in the study.
Who cannot join
- Unable to comprehend the study
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, PO6 3LY
About this study
Official title: SPECTRA: Investigating Signal Change in Malignant and Non-malignant Pleural Effusions and asCitic Fluid Using fTiR Analysis
Lung cancer is a common cancer, associated with a high mortality rate. Pleural effusions are common in lung cancer, developing in up to 40% of patients. Ascites is common in patients with abdominal malignancies and can be the presenting feature in up to 50% of patients. There is a need for new techniques to improve our diagnostic ability of cancer. FTIR technology could enable a point-of-care test that would provide an initial diagnosis that may determine a change in treatment at the time of the investigation.
Read the detailed description
Lung cancer accounts for 13% of all new cancer cases in the UK and is the third most common cancer. However, lung cancer has the highest mortality rate, thought partly related to late diagnosis. Pleural effusions develop in up to 40% of patients with lung cancer, and can be the first presenting sign. Current methods of analysing pleural fluid are based on using Light's criteria to distinguish between exudates and transudates depending on the protein and LDH component of the fluid. However, this system does not discriminate between causes of exudative effusions for example malignant effusions vs infective causes. Pleural fluid cytology can identify malignant effusions but gives an average yield of 60% through a labour intensive and time consuming process. If pleural fluid cytology is non-diagnostic, patients require further invasive investigations such as local anaesthetic thoracoscopy, lymph node biopsies or image-guided biopsies to gain a tissue diagnosis. Therefore, determining an alternative, accurate method of diagnosing cancer at the earliest opportunity would reduce the need for further invasive investigations and would provide patients with increased treatment options, thereby increasing survival rates. There are differences in the biochemical composition of malignant and non-malignant effusions thereby offering an opportunity to develop alternative techniques of investigating the cause of these effusions.
Ascites is a common symptom of patients with various underlying cancers; most commonly breast cancer, colon cancer, gastrointestinal cancer and ovarian cancer, and is often associated with significant morbidity. However, up to 50% of patients with malignant ascites present with ascites as the first feature. This symptom is not specific to any type of cancer; current investigations including using serum tumour markers have a low diagnostic specificity and there is a need for new techniques to improve our diagnostic ability.
Fourier transform mid-infrared spectroscopy (FTIR) is a reproducible and relatively simple investigation used to analyse the structural components of tissue or cells. As infrared light is passed through a sample, some light is absorbed and some transmitted through. The resulting signal at the detector presents as a spectrum, representing a 'molecular fingerprint' of the sample. Each chemical structure produces a unique spectral fingerprint making FTIR a useful tool for identifying components of tissue or cells.
Attenuated Total Reflection Linear Variable Filter (ATR-LVF) spectroscopy is a variant of IR spectroscopy in which samples can be examined directly with no preparation needed. ATR-LVF spectroscopy can be performed on benchtop spectrometers with minimal operator training and an immediate result can be obtained.
Both FTIR and ATR-LVF are non-invasive, reproducible, do not damage the sample and have the benefit of only requiring a small sample size to generate results all of which are desirable qualities in developing a new investigation.
FTIR has been used to successfully discriminate between malignant and non-malignant lung tissue6, and also to identify spectral differences in samples of pleural fluid from malignant and non-malignant participants. There is currently ongoing work investigating FTIR in diagnosing malignant pleural mesothelioma and initial results have shown significant spectral differences in this population too. There is very little information regarding the use of FTIR in assessing ascitic fluid. However, despite the technology, it is not available as a bedside point-of-care test for clinicians. The differences and discrimination of the model has not been tested prospectively to determine sensitivity and specificity of the FTIR test. A mobile point-of-care devices that may be able to provide rapid diagnostic results. This study aims to confirm that the spectral changes between malignant and non-malignant samples are present in a UK population in both pleural effusions and ascites.
- Conditions
- Pleural Effusion, Ascites
- Medical subject headings
- Pleural Effusion, Ascites
What is being measured
The primary outcome is the main question the study is designed to answer.
to detect signal difference between malignant and non-malignant pleural effusions
Measured using Fourier transform mid-infrared spectroscopy (FTIR) signal from pleural effusions
Measured: immediately after procedure
To detect a signal difference between malignant and non-malignant ascites
Measured using Fourier transform mid-infrared spectroscopy (FTIR) signal from ascitic fluid
Measured: immediately after procedure
do detect signal difference between malignant and non-malignant pleural effusions
Measured using attenuated Total Reflection Linear Variable Filter (ATR-LVF) spectroscopy signal from pleural effusions
Measured: immediately after procedure
To detect a signal difference between malignant and non-malignant ascites
measured using ttenuated Total Reflection Linear Variable Filter (ATR-LVF) spectroscopy signal from ascitic fluid
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start26 Mar 2021
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533854
- Sponsor's protocol ID
- PHT/2020/36
- Acronym
- SPECTRA
- Status last verified
- Sep 2022
- First submitted
- 26 Aug 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECTRA: Investigating Signal Change in Malignant and Non-malignant Pleural Effusions and asCitic Fluid Using fTiR Analysis
- ClinicalTrials.gov ID
- NCT04533854
- Acronym / sponsor ID
- SPECTRA / PHT/2020/36
- Conditions
- Pleural Effusion, Ascites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 1 Sep 2020 (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.
Lung cancer is a common cancer, associated with a high mortality rate. Pleural effusions are common in lung cancer, developing in up to 40% of patients. Ascites is common in patients with abdominal malignancies and can be the presenting feature in up to 50% of patients. There is a need for new techniques to improve our diagnostic ability of cancer. FTIR technology could enable a point-of-care test that would provide an initial diagnosis that may determine a change in treatment at the time of the investigation.
Detailed description
Lung cancer accounts for 13% of all new cancer cases in the UK and is the third most common cancer. However, lung cancer has the highest mortality rate, thought partly related to late diagnosis. Pleural effusions develop in up to 40% of patients with lung cancer, and can be the first presenting sign. Current methods of analysing pleural fluid are based on using Light's criteria to distinguish between exudates and transudates depending on the protein and LDH component of the fluid. However, this system does not discriminate between causes of exudative effusions for example malignant effusions vs infective causes. Pleural fluid cytology can identify malignant effusions but gives an average yield of 60% through a labour intensive and time consuming process. If pleural fluid cytology is non-diagnostic, patients require further invasive investigations such as local anaesthetic thoracoscopy, lymph node biopsies or image-guided biopsies to gain a tissue diagnosis. Therefore, determining an alternative, accurate method of diagnosing cancer at the earliest opportunity would reduce the need for further invasive investigations and would provide patients with increased treatment options, thereby increasing survival rates. There are differences in the biochemical composition of malignant and non-malignant effusions thereby offering an opportunity to develop alternative techniques of investigating the cause of these effusions.
Ascites is a common symptom of patients with various underlying cancers; most commonly breast cancer, colon cancer, gastrointestinal cancer and ovarian cancer, and is often associated with significant morbidity. However, up to 50% of patients with malignant ascites present with ascites as the first feature. This symptom is not specific to any type of cancer; current investigations including using serum tumour markers have a low diagnostic specificity and there is a need for new techniques to improve our diagnostic ability.
Fourier transform mid-infrared spectroscopy (FTIR) is a reproducible and relatively simple investigation used to analyse the structural components of tissue or cells. As infrared light is passed through a sample, some light is absorbed and some transmitted through. The resulting signal at the detector presents as a spectrum, representing a 'molecular fingerprint' of the sample. Each chemical structure produces a unique spectral fingerprint making FTIR a useful tool for identifying components of tissue or cells.
Attenuated Total Reflection Linear Variable Filter (ATR-LVF) spectroscopy is a variant of IR spectroscopy in which samples can be examined directly with no preparation needed. ATR-LVF spectroscopy can be performed on benchtop spectrometers with minimal operator training and an immediate result can be obtained.
Both FTIR and ATR-LVF are non-invasive, reproducible, do not damage the sample and have the benefit of only requiring a small sample size to generate results all of which are desirable qualities in developing a new investigation.
FTIR has been used to successfully discriminate between malignant and non-malignant lung tissue6, and also to identify spectral differences in samples of pleural fluid from malignant and non-malignant participants. There is currently ongoing work investigating FTIR in diagnosing malignant pleural mesothelioma and initial results have shown significant spectral differences in this population too. There is very little information regarding the use of FTIR in assessing ascitic fluid. However, despite the technology, it is not available as a bedside point-of-care test for clinicians. The differences and discrimination of the model has not been tested prospectively to determine sensitivity and specificity of the FTIR test. A mobile point-of-care devices that may be able to provide rapid diagnostic results. This study aims to confirm that the spectral changes between malignant and non-malignant samples are present in a UK population in both pleural effusions and ascites.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants with pleural effusions or ascites will be recruited from outpatient clinics, day units within the hospital and from inpatient wards. Only participants already having a diagnostic or therapeutic procedure as part of their standard medical care will be invited to take part.
Key inclusion criteria (10 listed)
- Aged ≥18 years.
- A confirmed, clinician made diagnosis of the following (supported by standard accepted diagnostic criteria):
- Malignant pleural effusion: confirmed cancer
- lung cancer
- mesothelioma
Key exclusion criteria (2 listed)
- Unable to comprehend the study
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to detect signal difference between malignant and non-malignant pleural effusions
Time frame: immediately after procedure
Measured using Fourier transform mid-infrared spectroscopy (FTIR) signal from pleural effusions
To detect a signal difference between malignant and non-malignant ascites
Time frame: immediately after procedure
Measured using Fourier transform mid-infrared spectroscopy (FTIR) signal from ascitic fluid
do detect signal difference between malignant and non-malignant pleural effusions
Time frame: immediately after procedure
Measured using attenuated Total Reflection Linear Variable Filter (ATR-LVF) spectroscopy signal from pleural effusions
To detect a signal difference between malignant and non-malignant ascites
Time frame: immediately after procedure
measured using ttenuated Total Reflection Linear Variable Filter (ATR-LVF) spectroscopy signal from ascitic fluid
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pleural Effusion and Ascites, run by Portsmouth Hospitals NHS 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 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 18 Nov 2023. 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?
to detect signal difference between malignant and non-malignant pleural effusions (time frame: immediately after procedure). The study lists 4 primary outcomes in all. 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 18 Nov 2023.