Low Grade Ovarian Serous AdenocarcinomaNCT00488878
Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors
An observational study of Low Grade Ovarian Serous Adenocarcinoma and Malignant Ovarian Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. Collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Low Grade Ovarian Serous Adenocarcinoma, Malignant Ovarian Neoplasm, Ovarian Carcinoma
- What is being tested?
- Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2006to 1 May 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a low-grade tumor of Mullerian origin who sought treatment or a second opinion at MD Anderson Cancer Center (MDACC) at any point in the course of their disease and treatment (beginning in January 1950), and patients currently being treated at MDACC or seeking treatment or a second opinion in the future
Who may be able to join
- Patients whose disease progressed to a higher-grade carcinoma since the time of original diagnosis:
- Ovarian tumor of low malignant potential
- Low-grade serous carcinoma of the ovary
- Primary peritoneal tumor of low malignant potential
- Low-grade serous carcinoma of the peritoneum
- Psammocarcinoma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
David M. Gershenson, 713-563-4535
David M. Gershenson
About this study
Official title: Data Collection for Patients With Low Grade Ovarian Carcinoma
This study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. Collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments for them.
Read the detailed description
PRIMARY OBJECTIVES:
- To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1600 female patients with low-grade ovarian and peritoneal tumors.
II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.
III. To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research.
SECONDARY OBJECTIVE:
- To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank.
OUTLINE:
Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.
- Conditions
- Low Grade Ovarian Serous Adenocarcinoma, Malignant Ovarian Neoplasm, Ovarian Carcinoma, Primary Peritoneal Carcinoma, Primary Peritoneal Low Grade Serous Adenocarcinoma, Psammocarcinoma
- Being tested
- Biospecimen Collection, Electronic Health Record Review
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Patients' residual tissue samples are collected
Electronic Health Record ReviewOther
Medical records are reviewed
| Study group | Role | What they receive |
|---|---|---|
| Observational (electronic health record review) | Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective and retrospective data collection on disease characterization, treatment, and outcomes
Measured: Up to 28 years
Organization of clinical information
Will be done in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.
Measured: Up to 28 years
Creation of a single data repository to integrate clinical information and research findings
Measured: Up to 28 years
Secondary outcomes (1)
Collection and storage of human tumor samples for the establishment of a tumor bank
Measured: Up to 28 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study start19 May 2006
- Primary completion1 May 2034 (estimated)
- Study completion1 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Ovarian Serous AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Gershenson, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488878
- Sponsor's protocol ID
- 2006-0137
- Other IDs
- NCI-2020-13341, 2006-0137
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2007
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for Patients With Low Grade Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT00488878
- Acronym / sponsor ID
- 2006-0137
- Conditions
- Low Grade Ovarian Serous Adenocarcinoma, Malignant Ovarian Neoplasm, Ovarian Carcinoma, Primary Peritoneal Carcinoma, Primary Peritoneal Low Grade Serous Adenocarcinoma, Psammocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 19 May 2006 (actual)
- Primary completion
- 1 May 2034 (estimated)
- Study completion
- 1 May 2035 (estimated)
- First posted
- 20 Jun 2007 (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.
This study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. Collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments for them.
Detailed description
PRIMARY OBJECTIVES:
- To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1600 female patients with low-grade ovarian and peritoneal tumors.
II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.
III. To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research.
SECONDARY OBJECTIVE:
- To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank.
OUTLINE:
Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (electronic health record review) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a low-grade tumor of Mullerian origin who sought treatment or a second opinion at MD Anderson Cancer Center (MDACC) at any point in the course of their disease and treatment (beginning in January 1950), and patients currently being treated at MDACC or seeking treatment or a second opinion in the future
Key inclusion criteria (6 listed)
- Patients whose disease progressed to a higher-grade carcinoma since the time of original diagnosis:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biospecimen CollectionPatients' residual tissue samples are collected | Procedure or surgery | Observational (electronic health record review) |
| Electronic Health Record ReviewMedical records are reviewed | Other | Observational (electronic health record review) |
Primary outcome
Prospective and retrospective data collection on disease characterization, treatment, and outcomes
Time frame: Up to 28 years
Organization of clinical information
Time frame: Up to 28 years
Will be done in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.
Creation of a single data repository to integrate clinical information and research findings
Time frame: Up to 28 years
1 secondary outcome
Collection and storage of human tumor samples for the establishment of a tumor bank
Time frame: Up to 28 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Low Grade Ovarian Serous Adenocarcinoma
Active, not recruitingPhase 2
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
Fallopian Tube Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma
RecruitingPhase 1
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma
Active, not recruitingPhase 2
Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer
Ovarian Cancer, Low Grade Serous Carcinoma
Not yet recruitingPhase 2
Imlunestrant/Abemaciclib/Selinexor in Ovarian and Endometrial
Low Grade Ovarian Serous Adenocarcinoma, Endometrial Cancer
Active, not recruitingPhase 2
Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma
Malignant Neoplasms of Female Genital Organs
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.
David M Gershenson principal investigator
M.D. Anderson Cancer Center
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 Low Grade Ovarian Serous Adenocarcinoma and Malignant Ovarian Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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 6 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Nathan (713-745-3837, lcnathan@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective and retrospective data collection on disease characterization, treatment, and outcomes (time frame: Up to 28 years). The study lists 3 primary outcomes in all. 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 10 Aug 2026.