Thyroid CancerNCT04072731
SREBP1 as a Potential Biomarker Promotes Cell Proliferation and Invasion in Thyroid Cancer
An observational study of Thyroid Cancer, run by People's Hospital of Zhengzhou University at 1 site in China.
Trial summary
In this study, the investigators detected the expression of SREBP1 in thyroid cancer tissues, explored the biological functions of SREBP1 in thyroid cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- pathologic
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2016to 1 Jan 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: all of this patients were recruited from the Affiliated Cancer Hospital of Xiangya Medical School
Who may be able to join
- Clinical diagnosis of thyroid cancer Reciving thyroidectomy surgery No experience of radiation therapy Nice treatment compliance and follow-up regularly
Who cannot join
- Prior history of malignancy ; Radiotherapy history, chemotherapy history; Serious concomitant diseases ; Chronic renal insufficiency and liver dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Cancer Hospital of Xiangya Medical School
Changsha, Hunan, 410078
About this study
In this study, the investigators detected the expression of SREBP1 in thyroid cancer tissues, explored the biological functions of SREBP1 in thyroid cancer cells.
Read the detailed description
qRT-PCR and immunohistochemistry were used to detect the expression of SREBP1 in 96 pairs thyroid cancer tissues and the adjacent normal tissues. The following methods, including the MTS, colony-forming assay, flow cytometry and hoechst staining were used to detect the biological function of thyroid cancer cells based on SREBP1 interference or not.
- Conditions
- Thyroid Cancer
- Being tested
- pathologic
- Keywords
- thyroid cancer, SREBP1
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathologicOther
Also called radioiodine
All the enrolled patients were treated with whole resection and diagnosed by the Pathology Department based on the pathological evidence.
| Study group | Role | What they receive |
|---|---|---|
| thyroid cancer | the thyroid cancer was determined by the the Pathology Department based on the pathological evidence. Receives: Other: pathologic | |
| the adjacent thyroid tissues | the adjacent thyroid tissues was collected from the tissue that 3 centimeters from the thyroid cancer. Receives: Other: pathologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
disease recurrent of progression
Measured: average 5 years
Secondary outcomes (1)
theraputic efficacy
According to the ATA guideline, patients were divided into four group, including excellent response (ER),indeterminate response (IDR), biochemical incomplete response (BIR), structural incomplete response (SIR) after surgery and radioiodine treatment.
Measured: average 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start16 Jan 2016
- Primary completion30 Jul 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- People's Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Li, People's Hospital of Zhengzhou University
- Investigators
- Zhi Li, Prof., Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072731
- Sponsor's protocol ID
- SBQLL-2016-015
- Status last verified
- Aug 2019
- First submitted
- 16 Jan 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SREBP1 as a Potential Biomarker Promotes Cell Proliferation and Invasion in Thyroid Cancer
- ClinicalTrials.gov ID
- NCT04072731
- Acronym / sponsor ID
- SBQLL-2016-015
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, SREBP1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- People's Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 16 Jan 2016 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 28 Aug 2019 (actual)
- 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.
In this study, the investigators detected the expression of SREBP1 in thyroid cancer tissues, explored the biological functions of SREBP1 in thyroid cancer cells.
Detailed description
qRT-PCR and immunohistochemistry were used to detect the expression of SREBP1 in 96 pairs thyroid cancer tissues and the adjacent normal tissues. The following methods, including the MTS, colony-forming assay, flow cytometry and hoechst staining were used to detect the biological function of thyroid cancer cells based on SREBP1 interference or not.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thyroid cancer | – | Other: pathologicthe thyroid cancer was determined by the the Pathology Department based on the pathological evidence. |
| the adjacent thyroid tissues | – | Other: pathologicthe adjacent thyroid tissues was collected from the tissue that 3 centimeters from the thyroid cancer. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all of this patients were recruited from the Affiliated Cancer Hospital of Xiangya Medical School
Key inclusion criteria (1 listed)
- Clinical diagnosis of thyroid cancer Reciving thyroidectomy surgery No experience of radiation therapy Nice treatment compliance and follow-up regularly
Key exclusion criteria (1 listed)
- Prior history of malignancy ; Radiotherapy history, chemotherapy history; Serious concomitant diseases ; Chronic renal insufficiency and liver dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pathologicAlso: radioiodineAll the enrolled patients were treated with whole resection and diagnosed by the Pathology Department based on the pathological evidence. | Other | the adjacent thyroid tissues, thyroid cancer |
Primary outcome
progression-free survival
Time frame: average 5 years
disease recurrent of progression
1 secondary outcome
theraputic efficacy
Time frame: average 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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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 Li, Prof. principal investigator
Central South University
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 Cancer, run by People's Hospital of Zhengzhou University 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: average 5 years). 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 28 Aug 2019.