Thyroid TumorNCT01668238
Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
An observational study of Thyroid Tumor and Breast Tumor, run by XU Zhi at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Tumor, Breast Tumor
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Hospitalized patients undergoing thyroid and breast tumor sugery; 2. Healthy volunteers
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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zhi XU, PhD MD, 86-10-82267331, xuzhi123456@sohu.com
Long Cui, 82267328, cuilong1978@163.com
About this study
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.
Read the 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.
- Conditions
- Thyroid Tumor, Breast Tumor
- Keywords
- Thyroid tumor, Breast tumor, Fourier Transform Infrared Spectrometry, Tumor Diagnosis
- Medical subject headings
- Thyroid Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
pathologic findings
- 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XU Zhi
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor-investigator, XU Zhi, Peking University
- Investigators
- Zhi Xu, PhD MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668238
- Sponsor's protocol ID
- PUCRP201105
- Status last verified
- Aug 2012
- First submitted
- 7 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Benign and Malignant Thyroid and Breast Tumors by Fourier Transform Infrared Spectrometry
- ClinicalTrials.gov ID
- NCT01668238
- Acronym / sponsor ID
- PUCRP201105
- Conditions
- Thyroid Tumor, Breast Tumor
- Keywords
- Thyroid tumor, Breast tumor, Fourier Transform Infrared Spectrometry, Tumor Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- XU ZhiUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Hospitalized patients undergoing thyroid and breast tumor sugery; 2. Healthy volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi Xu, PhD MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Tumor and Breast Tumor, run by XU Zhi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi XU, PHD MD (86-10-82267331, xuzhi123456@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic findings (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2012.