Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
NCT ID: NCT01668238
Last Updated: 2012-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2011-08-31
2012-09-30
Brief Summary
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Detailed Description
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Process of malignant transformation of tissues and cells, first proteins, lipids, carbohydrates and nucleic acids constitute the main substance of tissue and cell structure, conformation, and the number of occurrence of significant changes in subsequent histological changes. Fourier transform infrared spectroscopy is the major molecular bond coupling between the atoms vibrational spectra and molecular rotational spectra.
In this study, consists of three phases:
Stage one:
Continuous enrollment requires inpatient surgery 300 cases of thyroid cancer patients and breast cancer patients, 200 cases of preoperative determination of tumor on the surface infrared spectroscopy, infrared spectroscopy of the anterior tumor tissue and lymph node surgery, measured in vivo; at the same time into the group of 50 patients healthy people, the determination of surface infrared spectroscopy of the thyroid and breast area. Paraffin pathological findings as the gold standard, the thyroid and breast cancer patients were divided into the benign group and malignant group, relatively healthy and good, the distribution of differences of the surface infrared spectrum of malignant group, while relatively good in the malignant group IR spectra of the distribution of differences.
Phase II:
Were enrolled, infrared spectroscopy and pathological specimens were collected at different stages. Paraffin pathological findings as the gold standard, were established two tumor surface, the infrared spectra of the fresh in vitro and in vivo for tumor benign or malignant diagnosis discrimination system.
Phase III:
Into the infrared spectra collected data on behalf of the above-mentioned discrimination system to verify its sensitivity, specificity and accuracy; both paraffin pathological findings as the gold standard to compare the infrared spectral discrimination systems and intraoperative frozen section pathology for the diagnosis of benign and malignant tumors correctly rate differences, to explore the clinical value of infrared spectroscopy discrimination system.
Conditions
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Keywords
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Study Design
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CROSS_SECTIONAL
Study Groups
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malignant tumor
Inpatients with malignant tumors of thyroid and breast
No interventions assigned to this group
benign tumor
Inpatients with benign tumors of thyroid and breast
No interventions assigned to this group
Healthy volunteers
Volunteers without thyroid or breast tumors
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Informed consent form is signed.
* An optical fibre and ATR probe can be applied to the operation field in process of open or laparoscopic surgery.
* Male or female between the age of 18 to 80.
* Patients can tolerate surgery and with non of these diseases: severe heart failure, liver failure, renal failure or respiratory failure.
* Informed consent form is signed.
* No thyroid or breast cancer according to the professional judgment of general surgeon.
* No thyroid or breast disease according to thyroid function tests and breast type B-ultrasonic test within 3 months.
Exclusion Criteria
* unstable situation in operation, such as anesthetic accidents or intraoperative cerebral vascular accident.
* From investigators' perspective patients do not suitable for the study
18 Years
80 Years
ALL
Yes
Sponsors
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Peking University
OTHER
XU Zhi
OTHER
Responsible Party
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XU Zhi
Professor
Principal Investigators
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Zhi Xu, PhD MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhi XU, PhD MD
Role: primary
Long Cui
Role: backup
Other Identifiers
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PUCRP201105
Identifier Type: -
Identifier Source: org_study_id