Endometrial NeoplasmsNCT00250783
Pre-Clinical Models in Gynecological Tumors A Tissue Repository
An observational study of Endometrial Neoplasms and Uterine Neoplasms, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of this study is to provide a repository for long-term storage of endometrial cancer tumor and normal tissue, ascites and serum. This material will be used in studies to better understand the molecular biology of endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Neoplasms, Uterine Neoplasms
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jan 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: tumor and normal tissues, ascites, and/or serum, and/or urine from women with malignant or premalignant gynecological conditions for which they are undergoing medically-indicated surgery, and normal tissues from women without malignancy who volunteer to donate serum and/or tissue at the time of medically indicated surgery.
Who may be able to join
- All patients undergoing hysterectomy, or who have endometrial cancer, and are under routine surveillance.
- Patients may have received prior hormonal, cytotoxic chemotherapy, irradiation or surgical therapy.
- Healthy post-menopausal and peri-menopausal women.
- A consent form must be signed by the patient prior to study entry.
Who cannot join
- Study Patients:
- Patients who do not have primary uterine corpus tumors.
- Patients with less than one gram of tumor tissue available to procurement.
- Controls:
- Patients unwilling to have their medical records reviewed for height, weight, and general medical history (see attached data sheets).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Pre-Clinical Models in Gynecological Tumors: A Tissue Repository
The purpose of this study is to provide a repository for long-term storage of endometrial cancer tumor and normal tissue, ascites and serum. This material will be used in studies to better understand the molecular biology of endometrial cancer.
Read the detailed description
BACKGROUND AND RATIONALE
This protocol will create a central repository for banking tumor and other tissues as well as serum from patients with uterine corpus tumors. In addition, this protocol will also serve as a central repository for serum and tissue to healthy post-menopausal and peri-menopausal controls.
There will be an "internal" bank. The internal bank will have samples available to UNM investigators.
- Conditions
- Endometrial Neoplasms, Uterine Neoplasms
- Keywords
- Corpus Uteri, Endometrium, Cancer
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startJul 2002
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harriet Smith, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250783
- Sponsor's protocol ID
- 2902C
- Status last verified
- Mar 2024
- First submitted
- 4 Nov 2005
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Clinical Models in Gynecological Tumors: A Tissue Repository
- ClinicalTrials.gov ID
- NCT00250783
- Acronym / sponsor ID
- 2902C
- Conditions
- Endometrial Neoplasms, Uterine Neoplasms
- Keywords
- Corpus Uteri, Endometrium, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jul 2002 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Nov 2005 (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 purpose of this study is to provide a repository for long-term storage of endometrial cancer tumor and normal tissue, ascites and serum. This material will be used in studies to better understand the molecular biology of endometrial cancer.
Detailed description
BACKGROUND AND RATIONALE
This protocol will create a central repository for banking tumor and other tissues as well as serum from patients with uterine corpus tumors. In addition, this protocol will also serve as a central repository for serum and tissue to healthy post-menopausal and peri-menopausal controls.
There will be an "internal" bank. The internal bank will have samples available to UNM investigators.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tumor and normal tissues, ascites, and/or serum, and/or urine from women with malignant or premalignant gynecological conditions for which they are undergoing medically-indicated surgery, and normal tissues from women without malignancy who volunteer to donate serum and/or tissue at the time of medically indicated surgery.
Key inclusion criteria (4 listed)
- All patients undergoing hysterectomy, or who have endometrial cancer, and are under routine surveillance.
- Patients may have received prior hormonal, cytotoxic chemotherapy, irradiation or surgical therapy.
- Healthy post-menopausal and peri-menopausal women.
- A consent form must be signed by the patient prior to study entry.
Key exclusion criteria (5 listed)
- Patients who do not have primary uterine corpus tumors.
- Patients with less than one gram of tumor tissue available to procurement.
- Patients unwilling to have their medical records reviewed for height, weight, and general medical history (see attached data sheets).
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
Not reported in the source record.
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 12 Mar 2024.
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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.
Harriet Smith, MD principal investigator
University of New Mexico
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 Endometrial Neoplasms and Uterine Neoplasms, run by University of New Mexico 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 4 inclusion and 5 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 12 Mar 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 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?
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.
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 12 Mar 2024.