Investigating Signal Change in Malignant and Non-malignant Pleural Effusions and asCitic Fluid Using fTiR Analysis

NCT04533854 | Completed

• 1 other identifier: PHT/2020/36
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pleural Effusion; Ascites

Outcome Measures

Primary Outcomes (4)

• to detect signal difference between malignant and non-malignant pleural effusions

  Measured using Fourier transform mid-infrared spectroscopy (FTIR) signal from pleural effusions

  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

  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

  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

  immediately after procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• Unable to comprehend the study
• Unable to provide informed consent

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pleural fluid and ascitic fluid

MeSH Terms

Conditions

Pleural Effusion; Ascites

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: March 26, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: November 18, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)