Galactin 3-thyroid CarcinomaNCT05699590
Galectin-3 in Papillary Thyroid Carcinoma
An observational study of Galactin 3-thyroid Carcinoma, run by Sohag University.
Trial summary
Thyroid cancer is a common head and neck malignancy. It is the most common endocrine tumor in the body accounting for 1% of all cancers worldwide. The incidence of thyroid cancer varies worldwide. Most countries have reported an upward trend in its incidence. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Galactin 3-thyroid Carcinoma
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Jun 2023
- 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 20 to 90 years
- All sexes
- Adult, Older adult
Study population: Formalin fixed and paraffin embedded prostatic tissue blocks from 70 patients
Who may be able to join
- Thyroidectomy specimens both hemithyroidectomy and total thyroidectomy.
- All the studied cases include sufficient materials for the immunohistochemical study.
- Complete clinical data
Who cannot join
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
- Insufficient or tiny tissue biopsies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Galectin-3 Immunoreactivity in Papillary Thyroid Carcinoma
Thyroid cancer is a common head and neck malignancy. It is the most common endocrine tumor in the body accounting for 1% of all cancers worldwide. The incidence of thyroid cancer varies worldwide. Most countries have reported an upward trend in its incidence.
Thyroid cancer encompass the most common well-differentiated papillary carcinoma (80% of all thyroid cancers) and follicular carcinoma (15%), as well as poorly differentiated carcinoma (< 1%) and anaplastic carcinoma (< 2%).
Read more
Papillary thyroid carcinomas (PTCs) are the most commonly encountered thyroid malignancies. The diagnosis of PTC is based on the special nuclear features such as overlapping of nuclei, intranuclear inclusions, optical clearing, anisonucleosis and nuclear grooves. However, it is often difficult to differentiate PTC from benign papillary thyroid hyperplasia . As differentiation between benign or malignant thyroid lesions has clinical, therapeutic, and prognostic significance, it is necessary to make accurate diagnosis by using biomarkers.
Recently, a large number of immunohistochemical (IHC) markers have been studied to assist in differentiating non-neoplastic lesions from malignant thyroid lesions. CK19, galectin-3, TG, Ki67, BRAF, calcitonin, HBME-1, TTF-1, and RET are some of the examples of these IHC markers.
Galectin-3 is a 31-kDa β-galactoside binding lectin. It has been shown to be expressed by several types of non-neoplastic and neoplastic cells, and it is involved in cell-cell adhesion and in cell-matrix interactions.
- Conditions
- Galactin 3-thyroid Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis and prognosis of papillary thyroid carcinoma both classic variant and follicular variant
evaluation of Galectin-3 Immunostaining in Papillary Thyroid Carcinoma
Measured: Two or three days after staining tissue sections with Galactin 3 antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Galactin 3-thyroid CarcinomaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ahmed Abdelnaby, Sohag University
- Investigators
- Amira Ahmed Abdelnaby, Lecturer, Principal investigator, Pathology department, Faculty of medicine ,Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699590
- Sponsor's protocol ID
- Soh-Med-23-1-35
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galectin-3 Immunoreactivity in Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT05699590
- Acronym / sponsor ID
- Soh-Med-23-1-35
- Conditions
- Galactin 3-thyroid Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 26 Jan 2023 (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.
Thyroid cancer is a common head and neck malignancy. It is the most common endocrine tumor in the body accounting for 1% of all cancers worldwide. The incidence of thyroid cancer varies worldwide. Most countries have reported an upward trend in its incidence.
Thyroid cancer encompass the most common well-differentiated papillary carcinoma (80% of all thyroid cancers) and follicular carcinoma (15%), as well as poorly differentiated carcinoma (< 1%) and anaplastic carcinoma (< 2%).
Papillary thyroid carcinomas (PTCs) are the most commonly encountered thyroid malignancies. The diagnosis of PTC is based on the special nuclear features such as overlapping of nuclei, intranuclear inclusions, optical clearing, anisonucleosis and nuclear grooves. However, it is often difficult to differentiate PTC from benign papillary thyroid hyperplasia . As differentiation between benign or malignant thyroid lesions has clinical, therapeutic, and prognostic significance, it is necessary to make accurate diagnosis by using biomarkers.
Recently, a large number of immunohistochemical (IHC) markers have been studied to assist in differentiating non-neoplastic lesions from malignant thyroid lesions. CK19, galectin-3, TG, Ki67, BRAF, calcitonin, HBME-1, TTF-1, and RET are some of the examples of these IHC markers.
Galectin-3 is a 31-kDa β-galactoside binding lectin. It has been shown to be expressed by several types of non-neoplastic and neoplastic cells, and it is involved in cell-cell adhesion and in cell-matrix interactions.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Formalin fixed and paraffin embedded prostatic tissue blocks from 70 patients
Key inclusion criteria (3 listed)
- Thyroidectomy specimens both hemithyroidectomy and total thyroidectomy.
- All the studied cases include sufficient materials for the immunohistochemical study.
- Complete clinical data
Key exclusion criteria (3 listed)
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
- Insufficient or tiny tissue biopsies
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
Diagnosis and prognosis of papillary thyroid carcinoma both classic variant and follicular variant
Time frame: Two or three days after staining tissue sections with Galactin 3 antibody
evaluation of Galectin-3 Immunostaining in Papillary Thyroid Carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: Undecided
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.
Amira Ahmed Abdelnaby, Lecturer principal investigator
Pathology department, Faculty of medicine ,Sohag university
Questions about this trial
What is this clinical trial studying?
An observational study of Galactin 3-thyroid Carcinoma, run by Sohag University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Amira A Abdelnaby, Lecturer (01002097612, ameraabdelnaby55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis and prognosis of papillary thyroid carcinoma both classic variant and follicular variant (time frame: Two or three days after staining tissue sections with Galactin 3 antibody). 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 27 Jan 2023.