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

NCT02554565 | Terminated

• 1 other identifier: IC 2013-06
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

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.

Conditions

Cervical Cancer

Keywords

Patients with cervical cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences.

  Until 2 years after treatment

• Detailed molecular characterization of genes alterations implicated in cervical oncogenesis.

  Until 2 years after treatment

Study Arms (1)

Tumor biopsies and blood sampling

OTHER

Procedure: Tumor biopsy; Procedure: Blood sampling

Interventions

Tumor biopsy PROCEDURE

Tumor biopsy before treatment

Tumor biopsies and blood sampling

Blood sampling PROCEDURE

Blood sample before, during and after treatment

Tumor biopsies and blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with cervical cancer, at any stage, before any anti-tumoral treatment.
• Age ≥ 18 years.
• Patient information and signature of the informed consent or her/his legal representative.
• 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.

You may not qualify if:

• Person deprived of liberty or under supervision.
• Inability to attend scheduled follow-up visits for any psychological, sociological or geographical reasons.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (4)

CHU Besançon

Besançon, 25000, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: September 18, 2015
• Study Start: July 29, 2014
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: September 8, 2025

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)