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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06965 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ROR1905 | Other Identifier | Mayo Clinic in Rochester | |
| 19-011924 | Other Identifier | Mayo Clinic Institutional Review Board |
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This study collects blood samples to determine if the DNA of HPV that causes cervical cancer can be detected in patients with cervical cancer that is new (primary), has come back (recurrent), or has spread to other places in the body (metastatic) and are undergoing treatment with surgery, radiotherapy, chemotherapy, and/or immunotherapy. Researchers may use this information to predict response (good or bad) of the cervical cancer to treatment and detect recurrent cancer sooner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive chemoradiotherapy patients | Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, on the day of the final fraction of radiotherapy, at 3 months post-radiotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with undetectable circulating tumor deoxyribonucleic acid (ctDNA) posttreatment in patients with detectable ctDNA pre-treatment | The proportion will be reported along with the exact 95% binomial confidence interval. Additionally will report the mean standard deviation and median interquartile range ctDNA post-treatment in these patients. | At 6 weeks post-surgery (cohort 1), at 4-6 weeks after completion of chemotherapy and radiation (cohort 2), 4-6 weeks post End of chemotherapy and radiotherapy (cohort 3), at 8 weeks after start of chemotherapy or immunotherapy (cohort 4) |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA levels | Will be associated with Federation of Gynecology and Obstetrics stage and assessed using linear regression, reporting the correlation as well as the model estimates. | Baseline |
| Clinical tumor response |
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Inclusion Criteria:
Able to provide written consent
Patient has given permission to give tumor/blood sample for research testing
Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix
Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV
Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits
Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis
Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC)
Exclusion Criteria:
Other active malignancy =< 2 years prior to registration.
Pregnancy or lactation
Inability on the part of the patient to understand the informed consent to be compliant with the protocol
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Women ages 18 and older presenting with p16-positive or HPV-positive invasive carcinoma of the cervix cancer with plan to undergo therapy at Mayo Clinic Rochester or the University of Minnesota.
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| Name | Affiliation | Role |
|---|---|---|
| Allison E. Garda, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Blood
Will be assessed for association with baseline and post-treatment ctDNA using logistic regression. Depending on the number of tumor response, or non-response patients whichever is fewer, multiple variable models may be considered including additional relevant baseline covariates such as disease stage.
| At post-treatment assessment, assessed up to 2 years |
| Radiographic tumor response | Will be assessed for association with baseline and post-treatment ctDNA using logistic regression. Depending on the number of tumor response, or non-response patients whichever is fewer, multiple variable models may be considered including additional relevant baseline covariates such as disease stage. | At post-treatment assessment, assessed up to 2 years |
| Recurrence-free survival | Baseline ctDNA and ctDNA at measured time points will be considered in Cox models. | Up to 2 years |
| Overall survival | Baseline ctDNA and ctDNA at measured time points will be considered in Cox models. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage. | Up to 2 years |
| ctDNA clearance kinetics | Will be correlated with recurrence-free survival. ctDNA other than at baseline will be considered in these models as a time dependent covariate. Depending on the number of events, multiple variable models may be considered including additional relevant baseline covariates such as disease stage. | Up to 2 years |
| ctDNA conversion | Will be correlated during the active monitoring phase with recurrence-free survival. | Up to 2 years |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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