Endometrial CancerNCT01150682
Role of Biomarkers in Endometrial Cancer Recurrence in Samples From Patients With Stage II, Stage III, or Stage IV Endometrial Cancer
An observational study of Endometrial Cancer, run by Gynecologic Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying the role of biomarkers in endometrial cancer recurrence in samples from patients with stage II, stage III, or… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- RNA analysis, reverse transcriptase-polymerase chain reaction and enzyme-linked immunosorbent assay
- How many people
- 865 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2015
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrioid endometrial cancer
- Stage II-IV disease
- Patients who were eligible and evaluated on the GOG-0210, Molecular Staging in Endometrial Cancer clinical trial, meeting the following criteria:
- Allowed their specimens and clinical data collected as part of their participation
- Have sufficient high-quality frozen primary tumor, formalin-fixed and paraffin-embedded (FFPE) primary tumor, and/or pre-operative serum for testing available
- Patients who underwent surgical staging as specified in the GOG-0210 protocol and described in the GOG Surgical Manual Protocol, including any of the following procedures:
- Hysterectomy
- Bilateral oophorectomy
- Washings as well as pelvic lymphadenectomy and para-aortic lymphadenectomy
- Non-cancerous endometrial tissue and fasting serum from control samples meeting the following criteria (controls):
- Underwent hysterectomy to treat uterine prolapse at the Albert Einstein Hospital and Montefiore Medical Center, in the Bronx, NY
- No uterine fibroids or prior cancer
PATIENT CHARACTERISTICS:
- Postmenopausal patients and controls
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Role of Sex Hormone and Insulin/IGF Axes in Endometrial Cancer Recurrence
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying the role of biomarkers in endometrial cancer recurrence in samples from patients with stage II, stage III, or stage IV endometrial cancer.
Read the detailed description
OBJECTIVES:
- To investigate the association of endometrioid adenocarcinoma (EA) recurrence with pre-operative serum levels of insulin, total and free insulin-like growth factor-I (IGF-I), IGF-II, insulin-like growth factor-binding protein-1 (IGFBP-1) and IGFB-3, estradiol, estrone, progesterone, and sex hormone-binding globulin (SHBG) in samples from patients with stage II-IV endometrial cancer evaluated on GOG-0210.
- To study the associations of EA recurrence with pre-treatment tumor expression of IGF-I, IGF-II, and IGFBP-1 and -3 mRNA in samples from these patients.
- To study the associations of EA recurrence with pre-treatment tumor expression of insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor in samples from these patients.
- To measure the correlations of serum (protein) and tissue (mRNA) levels of IGF-I, IGF-II, and IGFBP-1 and -3 from samples of patients with EA and participants without cancer.
OUTLINE: Banked serum and tumor tissues samples are analyzed for levels of insulin, total and free insulin-like growth factor (IGF-I), IGF-II, IGFBP-1 and IGFBP-3, estradiol, estrone, progesterone and sex hormone-binding globulin (SHBG); expression of IGF-I, IGF-II, IGFBP-1 and IGFBP -3 mRNA; and expression of the insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor by RT-PCR, IHC, and ELISA. Banked non-cancerous endometrial tissue and fasting serum samples from controls are also analyzed for IGF-I, IGF-II, IGFBP-1, and IGFBP-3 and compared with the results of endometrial adenocarcinoma (EA) samples.
Clinical information associated with each EA samples (i.e., age, BMI, performance status, race, ethnicity, tumor stage, size, histology and grade, surgical compliance and type of post surgical adjuvant therapy, overall survival, recurrence-free survival, site of first recurrence, and biomarker values and expression) is also collected.
PROJECTED ACCRUAL: A total of 815 patient specimens and 50 control specimens will be accrued for this study.
- Conditions
- Endometrial Cancer
- Being tested
- RNA analysis, reverse transcriptase-polymerase chain reaction, enzyme-linked immunosorbent assay, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- endometrial adenocarcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenosquamous cell carcinoma, endometrial clear cell carcinoma, endometrial papillary serous carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
enzyme-linked immunosorbent assayOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics: age, BMI, performance status, race, ethnicity
Tumor characteristics
Surgical compliance and type of surgical adjuvant therapy
Overall survival
Recurrence-free survival
Site of first recurrence
Biomarker values and expression levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial 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
- Enrolment
- 865 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Marc Gunter, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150682
- Sponsor's protocol ID
- CDR0000680598
- Other IDs
- GOG-8015
- Status last verified
- Aug 2010
- First submitted
- 24 Jun 2010
- Last updated
- 29 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sex Hormone and Insulin/IGF Axes in Endometrial Cancer Recurrence
- ClinicalTrials.gov ID
- NCT01150682
- Acronym / sponsor ID
- CDR0000680598
- Conditions
- Endometrial Cancer
- Keywords
- endometrial adenocarcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial adenosquamous cell carcinoma, endometrial clear cell carcinoma, endometrial papillary serous carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 865 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2010
- Primary completion
- Jul 2015 (estimated)
- First posted
- 25 Jun 2010 (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.
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying the role of biomarkers in endometrial cancer recurrence in samples from patients with stage II, stage III, or stage IV endometrial cancer.
Detailed description
OBJECTIVES:
- To investigate the association of endometrioid adenocarcinoma (EA) recurrence with pre-operative serum levels of insulin, total and free insulin-like growth factor-I (IGF-I), IGF-II, insulin-like growth factor-binding protein-1 (IGFBP-1) and IGFB-3, estradiol, estrone, progesterone, and sex hormone-binding globulin (SHBG) in samples from patients with stage II-IV endometrial cancer evaluated on GOG-0210.
- To study the associations of EA recurrence with pre-treatment tumor expression of IGF-I, IGF-II, and IGFBP-1 and -3 mRNA in samples from these patients.
- To study the associations of EA recurrence with pre-treatment tumor expression of insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor in samples from these patients.
- To measure the correlations of serum (protein) and tissue (mRNA) levels of IGF-I, IGF-II, and IGFBP-1 and -3 from samples of patients with EA and participants without cancer.
OUTLINE: Banked serum and tumor tissues samples are analyzed for levels of insulin, total and free insulin-like growth factor (IGF-I), IGF-II, IGFBP-1 and IGFBP-3, estradiol, estrone, progesterone and sex hormone-binding globulin (SHBG); expression of IGF-I, IGF-II, IGFBP-1 and IGFBP -3 mRNA; and expression of the insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor by RT-PCR, IHC, and ELISA. Banked non-cancerous endometrial tissue and fasting serum samples from controls are also analyzed for IGF-I, IGF-II, IGFBP-1, and IGFBP-3 and compared with the results of endometrial adenocarcinoma (EA) samples.
Clinical information associated with each EA samples (i.e., age, BMI, performance status, race, ethnicity, tumor stage, size, histology and grade, surgical compliance and type of post surgical adjuvant therapy, overall survival, recurrence-free survival, site of first recurrence, and biomarker values and expression) is also collected.
PROJECTED ACCRUAL: A total of 815 patient specimens and 50 control specimens will be accrued for this study.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| RNA analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| enzyme-linked immunosorbent assay | Other | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Patient characteristics: age, BMI, performance status, race, ethnicity
Tumor characteristics
Surgical compliance and type of surgical adjuvant therapy
Overall survival
Recurrence-free survival
Site of first recurrence
Biomarker values and expression levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
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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.
Marc Gunter, PhD principal investigator
Albert Einstein College of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Gynecologic Oncology Group.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2011. 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?
Results are not available in the source record.
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?
Patient characteristics: age, BMI, performance status, race, ethnicity. The study lists 7 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 29 Apr 2011.