Thyroid NeoplasmsNCT01954134
P53 in Differentiated Thyroid Cancer
An observational study of Thyroid Neoplasms, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is considered as radioiodine resistant or in another words in the process of dedifferentiation. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Thyroid Neoplasms
- How many people
- 199 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2010to Jan 2013
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 171 patients with an age range of 16-80 yrs (mean: 47.7±13.5 yrs) and a total of 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs) were included in this study.
Who may be able to join
- Patients who were diagnosed with DTC
- Treated with total and/or near-total thyroidectomy
- Referred for I-131 ablation therapy or low dose I-131 whole body scan (WBS)
- Between December 2010 and January 2013.
Who cannot join
- Dose 131-I given in another hospital
- Radioiodine treatment more than one year after thyroidectomy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cumhuriyet University, School of Medicine, Dept. of Nuclear Medicine
Sivas, 58140
About this study
Official title: P53 Antibody; Is it an Indicator of Dedifferentiated Thyroid Cancer?
In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is considered as radioiodine resistant or in another words in the process of dedifferentiation. The aim of the present study was to search a simple blood test that could lead to early identification of patients with dedifferentiation. In this respect, we investigate whether the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients with high levels of thyroglobulin (tg) and negative I-131 scan.
Read the detailed description
In the present study enrolled were 171 patients with mean age of 47.7±13.5 yrs (range; 16-80yrs) and 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs). 134 (78.4%) patients were female and 37 (21.6%) patients were male.
- Conditions
- Thyroid Neoplasms
- Keywords
- Tumor Suppressor Protein p53,, Iodine Radioisotopes
- Medical subject headings
- Thyroid 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 |
|---|---|---|
| thyroid cancer, healty | Thyroid cancer group: patients with differentiated or dedifferentiated thyroid cancer Healty: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
There was not any risk for patients.
Measured: with in the first 8-10 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startDec 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye HASBEK, M.D., Assistant Professor, Cumhuriyet University
- Investigators
- Zekiye Hasbek, M.D., Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954134
- Sponsor's protocol ID
- T-485
- Other IDs
- T-485
- Status last verified
- Sep 2013
- First submitted
- 11 Sep 2013
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu M, Mao C, Chen Q, Cu XW, Zhang WS. Serum p53 protein and anti-p53 antibodies are associated with increased cancer risk: a case-control study of 569 patients and 879 healthy controls. Mol Biol Rep. 2010 Jan;37(1):339-43. doi: 10.1007/s11033-009-9744-7. Epub 2009 Aug 20.
PubMed 19693693Muller M, Meyer M, Schilling T, Ulsperger E, Lehnert T, Zentgraf H, Stremmel W, Volkmann M, Galle PR. Testing for anti-p53 antibodies increases the diagnostic sensitivity of conventional tumor markers. Int J Oncol. 2006 Oct;29(4):973-80.
PubMed 16964393Hasbek Z, Turgut B, Erselcan T. p53 antibody: is it an indicator of dedifferentiated thyroid cancer? Ann Nucl Med. 2014 Jan;28(1):42-6. doi: 10.1007/s12149-013-0783-8.
PubMed 24234516
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P53 Antibody; Is it an Indicator of Dedifferentiated Thyroid Cancer?
- ClinicalTrials.gov ID
- NCT01954134
- Acronym / sponsor ID
- T-485
- Conditions
- Thyroid Neoplasms
- Keywords
- Tumor Suppressor Protein p53,, Iodine Radioisotopes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Oct 2013 (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.
In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is considered as radioiodine resistant or in another words in the process of dedifferentiation. The aim of the present study was to search a simple blood test that could lead to early identification of patients with dedifferentiation. In this respect, we investigate whether the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients with high levels of thyroglobulin (tg) and negative I-131 scan.
Detailed description
In the present study enrolled were 171 patients with mean age of 47.7±13.5 yrs (range; 16-80yrs) and 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs). 134 (78.4%) patients were female and 37 (21.6%) patients were male.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thyroid cancer, healty | – | –Thyroid cancer group: patients with differentiated or dedifferentiated thyroid cancer Healty: control group |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 171 patients with an age range of 16-80 yrs (mean: 47.7±13.5 yrs) and a total of 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs) were included in this study.
Key inclusion criteria (4 listed)
- Patients who were diagnosed with DTC
- Treated with total and/or near-total thyroidectomy
- Referred for I-131 ablation therapy or low dose I-131 whole body scan (WBS)
- Between December 2010 and January 2013.
Key exclusion criteria (2 listed)
- Dose 131-I given in another hospital
- Radioiodine treatment more than one year after thyroidectomy.
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
There was not any risk for patients.
Time frame: with in the first 8-10 months after surgery
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 1 Oct 2013.
- Results publication: PubMed 19693693Wu M, Mao C, Chen Q, Cu XW, Zhang WS. Serum p53 protein and anti-p53 antibodies are associated with increased cancer risk: a case-control study of 569 patients and 879 healthy controls. Mol Biol Rep. 2010 Jan;37(1):339-43. doi: 10.1007/s11033-009-9744-7. Epub 2009 Aug 20.
- Results publication: PubMed 16964393Muller M, Meyer M, Schilling T, Ulsperger E, Lehnert T, Zentgraf H, Stremmel W, Volkmann M, Galle PR. Testing for anti-p53 antibodies increases the diagnostic sensitivity of conventional tumor markers. Int J Oncol. 2006 Oct;29(4):973-80.
- Derived from this study: PubMed 24234516Hasbek Z, Turgut B, Erselcan T. p53 antibody: is it an indicator of dedifferentiated thyroid cancer? Ann Nucl Med. 2014 Jan;28(1):42-6. doi: 10.1007/s12149-013-0783-8.
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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.
Zekiye Hasbek, M.D. principal investigator
Cumhuriyet 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 Neoplasms, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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 1 Oct 2013. 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 Turkey (Türkiye). 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?
There was not any risk for patients. (time frame: with in the first 8-10 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01954134, which also lists 3 linked publications.
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 1 Oct 2013.