An observational study in Ovarian Serous Adenocarcinoma, Undifferentiated Carcinoma of Ovary and Cervical Cancer, sponsored by PX Biosolutions. Completed at 1 site in Australia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-30.
Sponsored by PX Biosolutions · Observational
This study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients. Such a study will allow the development of suitable immunological tools to be used in assessing response in a subsequent phase I study aiming at evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing tumors. In addition, this study will help defining the baseline cancer-associated immune responses in the selected patient population.
Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this study.
WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex vivo and cultured IFNg ELISpot as well as tetramer staining.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's enrollment of 15 is below the median of 220 across 429 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →This is the only study on the registry with PX Biosolutions as lead sponsor.
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Three type of patients will be enrolled in this study:
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Exclusion Criteria:
Patient with histologically confirmed diagnosis of cervical cancer or cervical intraepithelial neoplasia (grade 3) or of high-grade serous (or undifferentiated) ovarian cancer or patients with AML or CML confirmed by bone marrow biopsy or peripheral blood Not treated - prior standard of care therapy acceptable one blood sampling performed on the visit day
Procedure: Blood Sampling
Sampling of 80mL of whole blood
Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients
Direct and cultured IFNg ELISpot as well as direct tetramer staining assays will be set up and qualified for the detection WT-1, survivin and HPV16 E7 specific immune responses in cancer patients
Time frame: Baseline
Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients
Direct and Cultured IFNg ELISpot assays as well as tetramer staining assays will be used for the characterization of tumor specific immune responses in cancer patients
Time frame: Baseline
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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