Cervical Cancer
Conditions
Keywords
Patients with cervical cancer
Brief summary
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
Detailed description
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
Interventions
PROCEDURETumor biopsy
Tumor biopsy before treatment
PROCEDUREBlood sampling
Blood sample before, during and after treatment
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with cervical cancer, at any stage, before any anti-tumoral treatment. 2. Age ≥ 18 years. 3. Patient information and signature of the informed consent or her/his legal representative. 4. Patient having given her/his agreement for a second biopsy at diagnosis if the first one was performed outside of the center and was not cryopreserved.
Exclusion criteria
1. Person deprived of liberty or under supervision. 2. Inability to attend scheduled follow-up visits for any psychological, sociological or geographical reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease. | Until 2 years after treatment | Detection rate of circulating tumoral DNA with confidence interval of 95% of this rate. Description of the variability of this rate according to the initial stage of the disease, treatment and disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences. | Until 2 years after treatment | Correlation between the two PCR/NGS detection methods - appreciation of the NGS method sensitivity compared to the PCR. |
| Detailed molecular characterization of genes alterations implicated in cervical oncogenesis. | Until 2 years after treatment | The characterization of HPV types and HPV integration sites as well as the sequencing of representative panel of genes involved in the tumorigenesis pattway. |
Countries
France
Outcome results
None listed