TeratomaNCT00836121
Anterior Mediastinum Teratoma: A Case Report
An observational study of Teratoma, run by Faculdade de Medicina de Catanduva at 1 site in Brazil.
Trial summary
The investigators report a case of a 39-year-old man who presented an anterior mediastinal cystic mature teratoma. Those kind of tumor contain elements derived from more than one of the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a haphazard manner. Read more about this study
- Who is it for?
- Ages 39 to 39 years, men only
- Conditions the study is for
- Teratoma
- What is being tested?
- right thoracotomy
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2008to Dec 2008
- 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 39 to 39 years
- Men only
- No healthy volunteers
- Adult
Study population: primary care clinic
Who may be able to join
- Clinical diagnosis of mediastinum teratoma
Who cannot join
- Tumor absent
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de medicina de Catanduva
Catanduva, São Paulo, 15809-145
About this study
Official title: Case Report of a 39 Years Old Man That Has Been Cured by a Total Resection of a Anterior Mediastinum Teratoma.
The investigators report a case of a 39-year-old man who presented an anterior mediastinal cystic mature teratoma. Those kind of tumor contain elements derived from more than one of the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a haphazard manner. They arise from totipotent cells and, therefore, are primarily found in gonads, and more rarely in primitive cells kidnapped in other parts of the body. The tissues are immature to well differentiated and foreign to the anatomic site. Mature teratomas are either cystic or solid, although the cystic presentation predominates in gonadal sites. Benign teratomas are the most common mediastinal germ cell tumor, accounting 70% of the mediastinal germ cell tumors in children and 60% of those in adults. Immature teratomas are potentially malignant tumors; their prognosis is influenced by the anatomic site of the tumor, patient age, and the fraction of the tumor that is immature. Treatment of benign mediastinal teratoma includes complete surgical resection, with results in a excellent long-term cure rates. Complete resection of teratomas should be the goal of treatment.
- Conditions
- Teratoma
- Being tested
- right thoracotomy
- Keywords
- Teratoma, Mediastinum
- Medical subject headings
- Teratoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
right thoracotomyProcedure or surgery
complete surgical resection
| Study group | Role | What they receive |
|---|---|---|
| tumor | Not described Receives: Procedure: right thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TeratomaStudies 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 only
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina de Catanduva
- Sponsor type
- University, hospital or other
- Investigators
- Stella MF Giolo, student, Principal investigator, Faculdade de Medicina de Catanduva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836121
- Sponsor's protocol ID
- FAMECA2009
- Other IDs
- SMFG2009
- Status last verified
- Feb 2009
- First submitted
- 2 Feb 2009
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Report of a 39 Years Old Man That Has Been Cured by a Total Resection of a Anterior Mediastinum Teratoma.
- ClinicalTrials.gov ID
- NCT00836121
- Acronym / sponsor ID
- FAMECA2009
- Conditions
- Teratoma
- Keywords
- Teratoma, Mediastinum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Faculdade de Medicina de CatanduvaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Feb 2009 (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 investigators report a case of a 39-year-old man who presented an anterior mediastinal cystic mature teratoma. Those kind of tumor contain elements derived from more than one of the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a haphazard manner. They arise from totipotent cells and, therefore, are primarily found in gonads, and more rarely in primitive cells kidnapped in other parts of the body. The tissues are immature to well differentiated and foreign to the anatomic site. Mature teratomas are either cystic or solid, although the cystic presentation predominates in gonadal sites. Benign teratomas are the most common mediastinal germ cell tumor, accounting 70% of the mediastinal germ cell tumors in children and 60% of those in adults. Immature teratomas are potentially malignant tumors; their prognosis is influenced by the anatomic site of the tumor, patient age, and the fraction of the tumor that is immature. Treatment of benign mediastinal teratoma includes complete surgical resection, with results in a excellent long-term cure rates. Complete resection of teratomas should be the goal of treatment.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tumor | – | Procedure: right thoracotomy |
Who may qualify
- Ages
- 39 to 39 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Clinical diagnosis of mediastinum teratoma
Key exclusion criteria (1 listed)
- Tumor absent
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 |
|---|---|---|
| right thoracotomycomplete surgical resection | Procedure or surgery | tumor |
Primary outcome
cure
Time frame: one month 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 4 Feb 2009.
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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.
Stella MF Giolo, student principal investigator
Faculdade de Medicina de Catanduva
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 Teratoma, run by Faculdade de Medicina de Catanduva at 1 site in Brazil.
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 4 Feb 2009. 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 Brazil. 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?
cure (time frame: one month after surgery). 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 4 Feb 2009.