Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | March 2015 |
| End Date: | August 2015 |
| Contact: | Lara Patriquin, MD |
| Email: | larapatriquin@gmail.com |
| Phone: | (505) 332-5900 |
Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
This is a single center study to assess the efficacy of CyPath™ Early Detection Lung Cancer
Assay to detect lung cancer cells from deep lung sputum.
Assay to detect lung cancer cells from deep lung sputum.
Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) is a porphyrin that can label cancer cells by
reacting to the increased number of low-density lipoproteins coating the surface of cancer
cells and the porous nature of the cancer cell membrane, causing the cell to fluoresce under
specific wavelengths of light. The primary objective of this clinical trial is to determine
the clinical sensitivity and specificity of the CyPath™ Early Lung Cancer Detection Assay by
comparing sputum specimens from one cohort of Participants who are healthy with two
additional cohorts of Participants including individuals at high risk for lung cancer and
individuals diagnosed with lung cancer. Collection of the sputum samples from high-risk
individuals and lung cancer patients is complete.
Participants who satisfy the inclusion/exclusion criteria will be enrolled into the study
and assigned to the healthy cohort. Study staff will collect sputum samples, and each
subject's sputum specimen will be processed onto 12 microscope slides. The sputum samples
will be collected at the study site or at the Participant's home after explanation of the
collection procedure by study staff. Samples will be identified with an identification
number blinding the sample identity. Each subject's sputum specimen will be processed onto
13 microscope slides at the University of Texas Health Science Center of San Antonio
(UTHSCSA) Laboratory. The UTHSCSA laboratory will process each sputum sample onto slides
using the ThinPrep T2000 processor for use in the CyPath™ Early Lung Cancer Detection Assay.
Twelve slides from each sputum sample will be labeled with CyPath™. One slide will be
analyzed at UTHSCSA by a cytologist who will preform PAP staining for the presence of
macrophages. Macrophages are an indication that the sputum sample is form deep within the
lungs. A cytotechnologist will review the slide and record results on a specimen adequacy
form. The study will compare the results of the CyPath™ Assay among cohorts. bioAffinity
researchers who will be blinded as to the Participant's identity will perform the CyPath™
labeling and scoring of the slides. The study results of the healthy cohort will be used for
comparison with the results of a closed study in which the sputum from individuals at high
risk of lung cancer and individuals diagnosed with lung cancer was compared.
Findings of the CyPath™ assay will not be used in the diagnosis or treatment of
Participants.
reacting to the increased number of low-density lipoproteins coating the surface of cancer
cells and the porous nature of the cancer cell membrane, causing the cell to fluoresce under
specific wavelengths of light. The primary objective of this clinical trial is to determine
the clinical sensitivity and specificity of the CyPath™ Early Lung Cancer Detection Assay by
comparing sputum specimens from one cohort of Participants who are healthy with two
additional cohorts of Participants including individuals at high risk for lung cancer and
individuals diagnosed with lung cancer. Collection of the sputum samples from high-risk
individuals and lung cancer patients is complete.
Participants who satisfy the inclusion/exclusion criteria will be enrolled into the study
and assigned to the healthy cohort. Study staff will collect sputum samples, and each
subject's sputum specimen will be processed onto 12 microscope slides. The sputum samples
will be collected at the study site or at the Participant's home after explanation of the
collection procedure by study staff. Samples will be identified with an identification
number blinding the sample identity. Each subject's sputum specimen will be processed onto
13 microscope slides at the University of Texas Health Science Center of San Antonio
(UTHSCSA) Laboratory. The UTHSCSA laboratory will process each sputum sample onto slides
using the ThinPrep T2000 processor for use in the CyPath™ Early Lung Cancer Detection Assay.
Twelve slides from each sputum sample will be labeled with CyPath™. One slide will be
analyzed at UTHSCSA by a cytologist who will preform PAP staining for the presence of
macrophages. Macrophages are an indication that the sputum sample is form deep within the
lungs. A cytotechnologist will review the slide and record results on a specimen adequacy
form. The study will compare the results of the CyPath™ Assay among cohorts. bioAffinity
researchers who will be blinded as to the Participant's identity will perform the CyPath™
labeling and scoring of the slides. The study results of the healthy cohort will be used for
comparison with the results of a closed study in which the sputum from individuals at high
risk of lung cancer and individuals diagnosed with lung cancer was compared.
Findings of the CyPath™ assay will not be used in the diagnosis or treatment of
Participants.
Inclusion Criteria:
- Participants who have never smoked nor have known lung diseases
Exclusion Criteria:
- Severe obstructive lung disease
- Angina with minimal exertion
- Pregnancy
- Have or have had cancer other than lung cancer
- Worked in the mining Industry
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