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

August 14, 2012 updated by: XU Zhi
The purpose of this stage of study is to establish discriminant among healthy tissue, benign and malignant thyroid and breast tumors by fourier transform infrared spectrometry variables.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Hospitalized patients undergoing thyroid and breast tumor sugery;
  2. Healthy volunteers

Description

Patients:

  1. 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.

  2. 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

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
malignant tumor
Inpatients with malignant tumors of thyroid and breast
benign tumor
Inpatients with benign tumors of thyroid and breast
Healthy volunteers
Volunteers without thyroid or breast tumors

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pathologic findings
Time Frame: 12 months
  1. 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.
  2. Between Patients and healthy volunteers, discriminant are established among thyroid and breast tumors and healthy tissues.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
XU Zhi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhi Xu, PhD MD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PUCRP201105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings