Recurrent Cervical Carcinoma Clinical Trial
Official title:
Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
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.
PRIMARY OBJECTIVES: I. To estimate the ctDNA detection rate in cervix cancer patients undergoing surgery, radiotherapy, chemotherapy, and/or immunotherapy in the setting of primary, recurrent or metastatic disease. II. Association of ctDNA baseline levels and clearance kinetics with clinical and radiographic tumor response. III. To explore the association of detectable ctDNA at each time point with invasive recurrence-free survival and overall survival. IV. To explore the use of ctDNA for surveillance and detection of disease recurrence. V. To create a repository for future exploratory studies including analyzing changes in T cell and other immune cell subpopulations during and following therapy for cervix cancer. OUTLINE: Patients are assigned to 1 of 4 cohorts. COHORT 1: Patients undergo collection of blood samples at baseline prior to surgery, at 6 weeks, 3, 6, and 12 months post-surgery, every 6 months during year 2, and at the time of recurrence (if applicable). COHORT 2: Patients undergo collection of blood samples at baseline prior to the first fraction of radiation, during week 4 of radiotherapy, at 6 weeks, 3, 6, and 12 months post-radiotherapy, every 6 months during year 2, and at the time of recurrence (if applicable). COHORT 3: 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). COHORT 4: Patients undergo collection of blood samples at baseline prior to initiation of chemotherapy or immunotherapy, at 4 weeks and 8 weeks after initiation of chemotherapy or immunotherapy, every 3 months during years 1 and 2, and at the time of recurrence (if applicable). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03968406 -
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT03508570 -
Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
|
Phase 1 | |
| Completed |
NCT00309959 -
ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
|
Phase 2 | |
| Recruiting |
NCT04635956 -
Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas
|
Phase 2 | |
| Active, not recruiting |
NCT03439085 -
DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers
|
Phase 2 | |
| Recruiting |
NCT03987555 -
Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
|
||
| Terminated |
NCT03345784 -
Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers
|
Phase 1 | |
| Completed |
NCT01266460 -
Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00064077 -
Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
|
Phase 3 | |
| Active, not recruiting |
NCT02257528 -
Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer
|
Phase 2 | |
| Recruiting |
NCT05310383 -
Tislelizumab and Radiotherapy for Recurrent Cervical Cancer
|
Phase 2 | |
| Recruiting |
NCT05310331 -
Donafenib for Recurrent Cervical Cancer
|
Phase 2 | |
| Recruiting |
NCT05310305 -
PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer
|
||
| Completed |
NCT01281852 -
Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
|
Phase 1 | |
| Recruiting |
NCT05290935 -
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy: Multi-Center Trial
|
Phase 2 | |
| Recruiting |
NCT06238635 -
Dostarlimab and Cobolimab in Advanced Cervical Cancer
|
Phase 2 | |
| Completed |
NCT02921269 -
Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer
|
Phase 2 | |
| Recruiting |
NCT06157151 -
PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00499031 -
Cetuximab in Treating Patients With Persistent or Recurrent Cervical Cancer
|
Phase 2 | |
| Completed |
NCT00041093 -
Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer
|
Phase 2 |