Coronavirus Delays Mesothelioma Breath Test Clinical Trial

Mesothelioma Breath Test Clinical Trial Delayed

For the mesothelioma community, the coronavirus pandemic has impacted many things. Among them, potential changes in patient treatment plans, postponement of mesothelioma-related conferences and interruptions in research.

The Mesothelioma Applied Research Foundation’s annual symposium was among the many events postponed nationwide due to health concerns related to COVID-19. The symposium’s postponement also delays the start of a clinical trial. Attendees of the symposium could opt to participate in the Identification of Biomarkers for the Early Detection of Mesothelioma trial.

Detecting Mesothelioma Through a Breath Test

The postponed clinical trial will test a promising early detection method for pleural mesothelioma. Breath testing for early detection of mesothelioma has been the subject of many studies in the last decade.

This particular clinical trial is led by Michael Harbut M.D., M.P.H. He is a clinical professor of medicine at Michigan State University and the medical advisor for the International Association of Heat and Frost Insulators and Allied Workers. Previously, Dr. Harbut served as a board member for the Mesothelioma Applied Research Foundation.

Dr. Harbut’s study will use OwlStone Medical technology to collect breath samples from participants. Once collected, researchers can analyze the volatile organic compounds (VOC) within the breath. Researchers would test for biomarkers related to mesothelioma and pleural plaques. Identifying these biomarkers may indicate early warning signs of the asbestos-related diseases.

Dr. Harbut’s aim through the non-invasive testing at the symposium was to sample participants with:

To collect the breath samples, participants breathe into a mask for approximately 12 minutes. Dr. Harbut will analyze the molecules carried in the breath samples. He hopes to identify mesothelioma-specific biomarkers like SMRP within the samples. If Dr. Harbut is successful, this clinical trial may ease the difficulty of early mesothelioma detection.

Dr. Harbut hopes to have 300 study participants. Access to symposium attendants could have enabled him to test many people affected by asbestos exposure.

The study is anticipated to run through March 2022. However, it is unclear if the delay of the voluntary trial at the symposium will impact this date. There has not been an announcement concerning if the trial will be offered at the rescheduled International Symposium on Malignant Mesothelioma. At this time, the new date for the event has not been released.

Previous Research on Breath Tests for Mesothelioma

This is not the first time a breath test has been considered as a potential diagnostic tool for pleural mesothelioma.

A Belgium study analyzed patients’ breath in 2018. Researchers were able to differentiate between the following groups with 96% accuracy:

  • Pleural mesothelioma patients
  • Former asbestos workers
  • Patients with benign asbestos-related diseases

The completed study had a sample size of 330 participants. Dr. Harbut’s study, with a goal of 300 participants, may help validate these previous findings.

Multiple systematic reviews of breath analysis studies completed in the past two decades have found breath testing is a promising early detection tool. However, there are some gaps in the research completed thus far. Many researchers express concern over the small study sizes. A small sample size makes it difficult to draw definitive conclusions on the diagnostic efficacy.

Importance of Early Detection for Mesothelioma

For rare cancers like mesothelioma, early detection is imperative. There is currently no cure for the asbestos cancer, and mesothelioma survival rates decline in the later stages of disease.

Early detection is hindered by non-specific symptoms typical of mesothelioma. Often, the cancer isn’t diagnosed until it has progressed to the more aggressive stages.

If proven successful, the use of breath tests could:

  • detect the cancer in its early stages
  • enable patients to seek more aggressive treatments
  • improve prognosis and increase life expectancy

Advancements in Mesothelioma Research During the Pandemic

It’s unclear how the delay of clinical trials like this will impact the mesothelioma community. The long-term impact of the coronavirus pandemic on mesothelioma research remains to be seen. However, while progress may have stalled for some, there have been positive results released from other mesothelioma clinical trials.

For instance, one phase 3 trial sponsored by Bristol Myers Squibb achieved its overall survival goal. The trial studied the efficacy of Opdivo® and Yervoy® in previously untreated malignant pleural mesothelioma patients.

The study found there was a statistically significant improvement in overall patient survival when compared to patients treated with standard chemotherapy. Formal results from the study have yet to be released.

According to Sabine Maier, M.D., development lead, thoracic cancers, Bristol Myers Squibb, “[This] is another example of the established efficacy and safety of the dual immunotherapy combination seen in multiple tumor types.”

Even though some mesothelioma clinical trials are on hold for now, research continues to progress.