Biomarkers in Samples From Patients With Endometrial Cancer

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Specialized Program of Research Excellence (SPORE) in Endometrial Cancer

ClinicalTrials.gov ID

NCT01199250

Acronym / sponsor ID

GOG-8020

Conditions

Lynch Syndrome, Recurrent Uterine Corpus Carcinoma, Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer

Study type

Observational

Recruitment status

WithdrawnReason stopped: Not a treatment/applicable clinical trial

Enrolment

0 participants (actual)

Lead sponsor

Gynecologic Oncology GroupResearch network

Collaborators

National Cancer Institute (NCI)

Study start

Jan 2010 (actual)

Primary completion

May 2019 (actual)

Study completion

May 2019 (actual)

First posted

10 Sep 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.

Study design

Observational model

Other

Time perspective

Retrospective

Number of arms

1

Who may qualify

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

Patients with endometrial cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Clinical sensitivity and specificity of epigenetic biomarkers in a cohort of blind samples (Project 2)

   Time frame: 1 month

   ROC curves used to describe the discriminatory characteristics of candidate biomarkers. From the competing risk model, the coefficients of the clinicopathological covariates and the hypermethylation levels of each biomarker will indicate the association of these factors with each of the four types of survivals. The significance of association will be indicated by P-values, and hazard rates will also be provided.

2. Confirmation of CpG island loci frequently hypermethylated in EECs exhibiting recurrence (Project 2)

   Time frame: 1 month

   Proportion of methylated samples and 95% confidence interval calculated for each marker, recurrent and non-recurrent samples. Will determine statistical significance of mean difference in DMH methylation levels between methylated and non-methylated samples on basis of two-sided two sample t-tests or nonparametric Wilcoxon tests (if normality is in question). Binary methylation status tabulated with recurrence status to formulate 2 by 2 contingency table. Existence of significant association indicated by a <0.05 p-value from Chi-square test or Fisher test (in case of small counts).

3. Development of a molecular screening regimen to compliment family history risk assessment for the detection of Lynch syndrome (Project 3)

   Time frame: 1 month

4. Expression of candidate ERK1/2 substrates in the normal endometrium, primary endometrial cancers and endometrial cancer cell lines dependence of substrate phosphorylation on ERK (Project 4)

   Time frame: 1 month

5. Frequency of Lynch syndrome-related endometrial cancer and relationships between inherited and acquired DNA mismatch repair defects and clinicopathologic variables (Project 3)

   Time frame: 1 month

6. GSK3β inhibition as a therapeutic treatment of endometrial cancer and role of inhibiting other ERK substrates in endometrial cancer cell lines (Project 4)

   Time frame: 1 month

7. Identification of cognate FGF ligands and receptors expressed in normal endometrium and endometrial cancers (Project 1)

   Time frame: 1 month

   Loss of expression or overexpression for each of FGFs/FGFRs will be described using contingency tables and the overall between-group differences will be compared using Chi-square test or Fisher's exact test as appropriate. For each marker, the nuclear positivity and cytoplasmic positivity will be evaluated separately. Proportional hazards Cox models will be fitted for each FGFR receptor or FGF ligand to evaluate its effect on PFS, ECS, and OS. Multivariate Cox model will be developed while considering biomarkers that have shown trend of significance in univariate analyses (permuted p < 0.2).

8. Identification of profiles of CpG island hypermethylation for stratifying subtypes of EECs (Project 2)

   Time frame: 1 month

   Descriptive statistics including mean, median and standard deviation will be summarized for the recurrent and non-recurrent groups across the 54 samples. Graphical presentation of the data will be provided by use of box-whisker plots and scatter plots.

9. Predictive and prognostic accuracy of a panel of SNPs alone and with informative clinical, surgical, and pathologic variables in a cohort of Caucasian women with stage IB or IC vs IIIC endometrioid endometrial cancer from WUSM and GOG-0210 (Project 5)

   Time frame: 1 month

10. Relationship between ERK substrate phosphorylation status and upstream ERK signaling pathway activation in primary endometrial cancers and clinicopathologic significance of ERK substrate expression(Project 4)

    Time frame: 1 month

    The primary endpoints are protein amounts from quantitative Western blots and IHC-based ordinal scores describing intensity of staining and percentage of cells staining in the nucleus, cytoplasm and a combination of both locations.

11. Relationship between inherited variation in the MLH1 DNA repair gene and somatic (acquired) inactivation of MLH1 in sporadic endometrial cancer (Project 3)

    Time frame: 1 month

    The primary association analysis for the case-control association study will be 2 x 2 contingency table analysis using chi squared tests. The allele frequency for each SNP will be compared for all cases and controls.

12. Role of FGFR2 mutations in low, intermediate and high risk endometrial cancers (Project 1)

    Time frame: 1 month

    Clinical outcome in FGFR2 mutation carriers will be compared with survival for women with no mutations. Effect of the mutation over time using survival modeling also considered. OS and PFS described using Cox model. PFI time and ECS time described using competing risks model. Prognostic factors will be evaluated in univariate and multivariate analyses. Variables associated with each primary endpoint (OS, DFS, PHI and ECS) at the 10% level on the basis of univariate models will be introduced in the multivariate models. Significance levels for all analyses will be set at a p-value of 0.05.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.

1 site in 1 country: see every site and its status.