Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
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|ClinicalTrials.gov Identifier: NCT01668238|
Recruitment Status : Unknown
Verified August 2012 by XU Zhi, Peking University.
Recruitment status was: Recruiting
First Posted : August 20, 2012
Last Update Posted : August 20, 2012
|Condition or disease|
|Thyroid Tumor Breast Tumor|
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:
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.
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
Inpatients with malignant tumors of thyroid and breast
Inpatients with benign tumors of thyroid and breast
Volunteers without thyroid or breast tumors
- pathologic findings [ Time Frame: 12 months ]
- In operation patients, discriminant between benign and malignant thyroid and breast tumors are established by fourier transform infrared spectrometry variables, and pathologic diagnoses are gold standard.
- Between Patients and healthy volunteers, discriminant are established among thyroid and breast tumors and healthy tissues.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668238
|Contact: Zhi XU, PHD MDfirstname.lastname@example.org|
|Contact: Long Cuiemail@example.com|
|Peking University Third Hospital||Recruiting|
|Beijing, Beijing, China, 100191|
|Contact: Zhi XU, PhD MD 86-10-82267331 firstname.lastname@example.org|
|Contact: Long Cui 82267328 email@example.com|
|Principal Investigator:||Zhi Xu, PhD MD||Peking University Third Hospital|