Suspended

Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Breast Diseases+8

+ Endocrine System Diseases

+ Endocrine Gland Neoplasms

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: August 2011
See protocol details

Summary

Principal SponsorXU Zhi
Study ContactZhi XU, PHD MDMore contacts
Last updated: August 20, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2011

Actual date on which the first participant was enrolled.

Recently,the methods to the diagnosis of tumors include palpation,X-ray,ultrasound,CT and MRI.The doctors could not get conclusion without a existing mass.The FNB is very popular nowadays in western countries,but it has been reported that about one-third malignant cases have been neglected by FNB,for the tissue isn't enough through the needle.There also have been reports about the increased auxilliary lymphnode metastases for breast cancer because of FNB.Although the Mammotome has been used widely,it is still traumatic. 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.

Principal SponsorXU Zhi
Study ContactZhi XU, PHD MDMore contacts
Last updated: August 20, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesThyroid DiseasesSkin and Connective Tissue DiseasesBreast NeoplasmsThyroid Neoplasms

Criteria

Patients: Inclusion Criteria: Patients undergoing thyroid and breast tumor surgery. 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. Exclusion Criteria: A state of emergency, such as Gastrointestinal bleeding, perforation, or acute obstruction. unstable situation in operation, such as anesthetic accidents or intraoperative cerebral vascular accident. From investigators' perspective patients do not suitable for the study Healthy volunteers' inclusion criteria: 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Peking University Third Hospital

Beijing, ChinaOpen Peking University Third Hospital in Google Maps
SuspendedOne Study Center