Innovation for Standard Identification of Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cancer: Towards Development of Personalized Biomarkers in Clinical Oncology

Cervical Cancer Clinical Trial

— PAIR HPV  

Official title:

Innovation for Standard Identification for Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cance: Towards Development of Personalized Biomarkers in Clinical Oncology (PAIR HPV : Human PapillomaVirus)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02554565
• Other study ID #: IC 2013-06 PAIR HPV
• Status: Terminated
• Phase: N/A
• Start date: July 29, 2014
• Est. completion date: September 27, 2018

Study information

• Verified date: March 2019
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: September 27, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Tumor biopsy
Tumor biopsy before treatment
• Blood sampling
Blood sample before, during and after treatment

Locations

Country	Name	City	State
France	CHU Besançon	Besancon
France	Centre François Baclesse	Caen
France	Centre Jean Perrin	Clermont Ferrand
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Until 2 years after treatment
Secondary	Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences.	Correlation between the two PCR/NGS detection methods - appreciation of the NGS method sensitivity compared to the PCR.	Until 2 years after treatment
Secondary	Detailed molecular characterization of genes alterations implicated in cervical oncogenesis.	The characterization of HPV types and HPV integration sites as well as the sequencing of representative panel of genes involved in the tumorigenesis pattway.	Until 2 years after treatment