SEER DatabaseNCT04555395
The Differences Between Gonadal and Extra-gonadal Malignant Teratomas
An observational study of SEER Database, run by Shanghai 10th People's Hospital.
Trial summary
A tumor comprising of different types of tissues (such as hair, muscle, bone, etc.) is known as a teratoma. It is a type of germ cell (cells that make sperm or eggs) tumor. When these germ cells have rapid cancerous growth, then such a teratoma is called a malignant teratoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SEER Database
- What is being tested?
- survival rates
- How many people
- 3,799 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1973to 1 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The registry used in our study was the SEER 9 registries Custom Data (with additional treatment fields), Nov 2016 Submission (1973-2014) < Katrina/Rita Population Adjustment> - Linked to County Attributes -Total United States, 1969-2015 Counties, National Cancer Institute, DCCPS (Division of Cancer Control and Population Sciences), Surveillance Research Program, released April 2017, based on the November 2016 submission.
The registry used in our study was the SEER 9 registries Custom Data (with additional treatment fields), Nov 2016 Submission (1973-2014) < Katrina/Rita Population Adjustment> - Linked to County Attributes -Total United States, 1969-2015 Counties, National Cancer Institute, DCCPS (Division of Cancer Control and Population Sciences), Surveillance Research Program, released April 2017, based on the November 2016 submission.
About this study
Official title: The Differences Between Gonadal and Extra-gonadal Malignant Teratomas in Both Genders and the Effects of Chemotherapy
A tumor comprising of different types of tissues (such as hair, muscle, bone, etc.) is known as a teratoma. It is a type of germ cell (cells that make sperm or eggs) tumor. When these germ cells have rapid cancerous growth, then such a teratoma is called a malignant teratoma. We have studied the differences between gonadal and extra-gonadal malignant teratomas and the effects of chemotherapy in both genders.
Methods: The samples of 3799 male and 1832 female patients with malignant teratoma samples, between the ages of 1 and 85+ years, were selected from the years 1973 to 2014. Trends in incidence, estimated prevalence, incidence rates, and frequency were calculated in gonadal and extra-gonadal tumors with age adjustment. The fiveyear observed, expected, and relative survival rates were analyzed to study the prognosis.
- Conditions
- SEER Database
- Being tested
- survival rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survival ratesOther
survival rates
| Study group | Role | What they receive |
|---|---|---|
| gonadal | Not described Receives: Other: survival rates | |
| extra-gonadal | Not described Receives: Other: survival rates | |
| chemotherapy | Not described Receives: Other: survival rates | |
| without chemotherapy | Not described Receives: Other: survival rates |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rates
Measured: 1973-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Jan 1973
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SEER DatabaseStudies 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 3,799 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555395
- Sponsor's protocol ID
- malignant teratomas
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differences Between Gonadal and Extra-gonadal Malignant Teratomas in Both Genders and the Effects of Chemotherapy
- ClinicalTrials.gov ID
- NCT04555395
- Acronym / sponsor ID
- malignant teratomas
- Conditions
- SEER Database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,799 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 1973 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 18 Sep 2020 (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.
A tumor comprising of different types of tissues (such as hair, muscle, bone, etc.) is known as a teratoma. It is a type of germ cell (cells that make sperm or eggs) tumor. When these germ cells have rapid cancerous growth, then such a teratoma is called a malignant teratoma. We have studied the differences between gonadal and extra-gonadal malignant teratomas and the effects of chemotherapy in both genders.
Methods: The samples of 3799 male and 1832 female patients with malignant teratoma samples, between the ages of 1 and 85+ years, were selected from the years 1973 to 2014. Trends in incidence, estimated prevalence, incidence rates, and frequency were calculated in gonadal and extra-gonadal tumors with age adjustment. The fiveyear observed, expected, and relative survival rates were analyzed to study the prognosis.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| gonadal | – | Other: survival rates |
| extra-gonadal | – | Other: survival rates |
| chemotherapy | – | Other: survival rates |
| without chemotherapy | – | Other: survival rates |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The registry used in our study was the SEER 9 registries Custom Data (with additional treatment fields), Nov 2016 Submission (1973-2014) < Katrina/Rita Population Adjustment> - Linked to County Attributes -Total United States, 1969-2015 Counties, National Cancer Institute, DCCPS (Division of Cancer Control and Population Sciences), Surveillance Research Program, released April 2017, based on the November 2016 submission.
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 |
|---|---|---|
| survival ratessurvival rates | Other | chemotherapy, extra-gonadal, gonadal, without chemotherapy |
Primary outcome
survival rates
Time frame: 1973-2014
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 18 Sep 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of SEER Database, run by Shanghai 10th People's Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. 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?
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?
survival rates (time frame: 1973-2014). 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 18 Sep 2020; AzTrials last refreshed its copy on 29 Oct 2026.