Medullary Thyroid CancerDSR-MTCNCT06243965
Is Desmoplastic Stromal Reaction Useful to Modulate Lymph Node Dissection in Sporadic Medullary Thyroid Carcinoma?
An observational study of Medullary Thyroid Cancer and Medullary Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The oncologic benefit of lateral neck dissection (LND) during index operation for sporadic medullary thyroid carcinoma (MTC) basing on basal calcitonin (bCT) levels has been questioned due to the potential post-operative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Cancer, Medullary Carcinoma, Medullary Tumor
- How many people
- 246 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 1997to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults patients who underwent index procedure between January 1997 and December 2022 in our center for sporadic unifocal MTC whose specimens were retrospectively re-evaluated by an expert endocrine pathologist (E.D.R.) for DSR were candidates for inclusion.
Who may be able to join
- All adults patients who underwent index procedure for sporadic unifocal MTC whose specimens were retrospectively re-evaluated by an expert endocrine pathologist (E.D.R.) for DSR were candidates for inclusion.
Who cannot join
- hereditary MTC
- sporadic multifocal MTC
- index operation in another center
- incidental diagnosis of MCT after less than total thyroidectomy and bilateral central neck dissection
- less than 6-months-follow-up
- patients < 18 years old
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
About this study
The oncologic benefit of lateral neck dissection (LND) during index operation for sporadic medullary thyroid carcinoma (MTC) basing on basal calcitonin (bCT) levels has been questioned due to the potential post-operative complications. This study aims to evaluate desmoplastic reaction (DSR), as predictor of nodal metastases, for definition of surgical strategy.
Data from pathological report of MTC after operations between 1997 and 2022 were collected. The primary endpoint of the study was evaluating the risk factors for nodal metastases. The secondary endpoints analyzed the correlations between DSR and nodal metastases and the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of DSR for nodal metastases.
Read the detailed description
Medullary thyroid carcinoma (MTC) is a rare neuroendocrine tumor associated with aggressive biological behavior and a tendency for earlier lymphatic spread compared with differentiated thyroid carcinoma. Most MTCs are sporadic (75%), although some (25%) are hereditary, either familial or occurring in association with multiple endocrine neoplasia type 2 (MEN 2) syndrome. In contrast to hereditary MTC, sporadic MTC presents as multifocal disease only in 10% of patients.
As the most common clinical presentation is an asymptomatic solitary thyroid nodule, sporadic MTC detection is often late. Consequently, it is usually diagnosed as advanced disease, with cervical node involvement in most patients (70%) and compressive symptoms of the upper aerodigestive tract (15% of cases). Indeed, at the time of diagnosis, MTC presents with nodal involvement of central and lateral compartment in 50-81% and 34-81% of patients, respectively. Approximately 5% to 10% of patients with sporadic MTC even present with distant metastasis to the liver, lung, bones, brain and skin.
Complete surgical resection of the primary tumor and regional metastases is the cornerstone for locoregional disease control, since adjuvant therapy remains ineffective for the treatment of sporadic MTC. Moreover, as the number of positive lymph nodes and involved anatomical compartments are cancer-specific prognostic factors, early and accurate diagnosis of regional lymph nodes involvement is crucial for determining the surgical strategy. However, pre-operative diagnosis of MTC-related nodal disease is challenging due to the low sensitivity of imaging studies on detecting regional spread. Therefore, clinical decisions are often based upon biomarkers, mainly basal calcitonin levels, to predict nodal involvement and plan the surgical extent. Several associations have advocated in favor of this approach, although not with a strong recommendation, by suggesting prophylactic neck dissections based on basal calcitonin levels, especially for the lateral compartments. However, recent studies challenge this approach since a significant portion of patients were exposed to operations with increased morbidity without nodal spread on final histology or obvious survival benefits. As a consequence, the need to develop new predictive tools to tailor the surgical extent to each patient is paramount.
Desmoplasia, defined as the newly paraneoplastic formed stromal reaction surrounding the invasive epithelial tumor cells, has recently resurfaced as a morphological parameter with distinct clinical relevance in MTC. Significant correlation of desmoplasia with lymph node metastasis has been described in literature, with a higher specificity in predicting the nodal metastasizing pattern when compared with other morphological features. More specifically, the absence of desmoplasia on frozen section and definitive histopathology has been strongly associated with the absence of nodal metastases. As such, desmoplasia may have a crucial role in guiding surgical extent in the future.
The aim of this study is to evaluate the correlation between desmoplasia and nodal involvement in unifocal sporadic MTC in our experience.
- Conditions
- Medullary Thyroid Cancer, Medullary Carcinoma, Medullary Tumor, Medullary Neoplasms, Desmoplasia, Desmoplastic
- Keywords
- medullary thryoid carcinoma, desmoplasia, lateral neck dissection
- Medical subject headings
- Carcinoma, Medullary, Brain Stem Neoplasms, Fibrosis, Lymphatic Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for nodal metastases
The primary endpoint of the study consists in the evaluation of risk factors for nodal metastases in patients with histopathologic report of medullary thryoid carcinoma
Measured: January 1997-December 2022
Secondary outcomes (1)
Correlations between desmoplastic stromal reaction and nodal metastases
The secondary endpoints consist in the evaluation of correlations between desmoplastic stromal reaction and nodal metastases and in the sensitivity, specificity, PPV and PNV of desmoplastic stromal reaction for nodal metastases in patients with histopathologic report of medullary thyroid carcinoma
Measured: January 1997-December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Jan 1997
- Primary completion31 Dec 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary 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
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243965
- Sponsor's protocol ID
- 5547
- Acronym
- DSR-MTC
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Reasonable requests will be evaluated by the Principal Investigator of our study
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Desmoplastic Stromal Reaction Useful to Modulate Lymph Node Dissection in Sporadic Medullary Thyroid Carcinoma?
- ClinicalTrials.gov ID
- NCT06243965
- Acronym / sponsor ID
- DSR-MTC / 5547
- Conditions
- Medullary Thyroid Cancer, Medullary Carcinoma, Medullary Tumor, Medullary Neoplasms, Desmoplasia, Desmoplastic
- Keywords
- medullary thryoid carcinoma, desmoplasia, lateral neck dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 1997 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 6 Feb 2024 (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.
The oncologic benefit of lateral neck dissection (LND) during index operation for sporadic medullary thyroid carcinoma (MTC) basing on basal calcitonin (bCT) levels has been questioned due to the potential post-operative complications. This study aims to evaluate desmoplastic reaction (DSR), as predictor of nodal metastases, for definition of surgical strategy.
Data from pathological report of MTC after operations between 1997 and 2022 were collected. The primary endpoint of the study was evaluating the risk factors for nodal metastases. The secondary endpoints analyzed the correlations between DSR and nodal metastases and the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of DSR for nodal metastases.
Detailed description
Medullary thyroid carcinoma (MTC) is a rare neuroendocrine tumor associated with aggressive biological behavior and a tendency for earlier lymphatic spread compared with differentiated thyroid carcinoma. Most MTCs are sporadic (75%), although some (25%) are hereditary, either familial or occurring in association with multiple endocrine neoplasia type 2 (MEN 2) syndrome. In contrast to hereditary MTC, sporadic MTC presents as multifocal disease only in 10% of patients.
As the most common clinical presentation is an asymptomatic solitary thyroid nodule, sporadic MTC detection is often late. Consequently, it is usually diagnosed as advanced disease, with cervical node involvement in most patients (70%) and compressive symptoms of the upper aerodigestive tract (15% of cases). Indeed, at the time of diagnosis, MTC presents with nodal involvement of central and lateral compartment in 50-81% and 34-81% of patients, respectively. Approximately 5% to 10% of patients with sporadic MTC even present with distant metastasis to the liver, lung, bones, brain and skin.
Complete surgical resection of the primary tumor and regional metastases is the cornerstone for locoregional disease control, since adjuvant therapy remains ineffective for the treatment of sporadic MTC. Moreover, as the number of positive lymph nodes and involved anatomical compartments are cancer-specific prognostic factors, early and accurate diagnosis of regional lymph nodes involvement is crucial for determining the surgical strategy. However, pre-operative diagnosis of MTC-related nodal disease is challenging due to the low sensitivity of imaging studies on detecting regional spread. Therefore, clinical decisions are often based upon biomarkers, mainly basal calcitonin levels, to predict nodal involvement and plan the surgical extent. Several associations have advocated in favor of this approach, although not with a strong recommendation, by suggesting prophylactic neck dissections based on basal calcitonin levels, especially for the lateral compartments. However, recent studies challenge this approach since a significant portion of patients were exposed to operations with increased morbidity without nodal spread on final histology or obvious survival benefits. As a consequence, the need to develop new predictive tools to tailor the surgical extent to each patient is paramount.
Desmoplasia, defined as the newly paraneoplastic formed stromal reaction surrounding the invasive epithelial tumor cells, has recently resurfaced as a morphological parameter with distinct clinical relevance in MTC. Significant correlation of desmoplasia with lymph node metastasis has been described in literature, with a higher specificity in predicting the nodal metastasizing pattern when compared with other morphological features. More specifically, the absence of desmoplasia on frozen section and definitive histopathology has been strongly associated with the absence of nodal metastases. As such, desmoplasia may have a crucial role in guiding surgical extent in the future.
The aim of this study is to evaluate the correlation between desmoplasia and nodal involvement in unifocal sporadic MTC in our experience.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patients who underwent index procedure between January 1997 and December 2022 in our center for sporadic unifocal MTC whose specimens were retrospectively re-evaluated by an expert endocrine pathologist (E.D.R.) for DSR were candidates for inclusion.
Key inclusion criteria (1 listed)
- All adults patients who underwent index procedure for sporadic unifocal MTC whose specimens were retrospectively re-evaluated by an expert endocrine pathologist (E.D.R.) for DSR were candidates for inclusion.
Key exclusion criteria (6 listed)
- hereditary MTC
- sporadic multifocal MTC
- index operation in another center
- incidental diagnosis of MCT after less than total thyroidectomy and bilateral central neck dissection
- less than 6-months-follow-up
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
Risk factors for nodal metastases
Time frame: January 1997-December 2022
The primary endpoint of the study consists in the evaluation of risk factors for nodal metastases in patients with histopathologic report of medullary thryoid carcinoma
1 secondary outcome
Correlations between desmoplastic stromal reaction and nodal metastases
Time frame: January 1997-December 2022
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 6 Feb 2024.
- Individual participant dataSharing planned: Undecided. Reasonable requests will be evaluated by the Principal Investigator of our study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Medullary Thyroid Cancer and Medullary Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 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 6 Feb 2024. 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 Italy. 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?
Risk factors for nodal metastases (time frame: January 1997-December 2022). 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 6 Feb 2024.