Assess dominant mutations and activation pathways in cervical cancers predictive to standard treatment response.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Frequency of dominant genetic or protein alterations
• Non response to primary treatment at 6 months as determined by:
I Pathology
II Cross sectional imaging by MRI (pelvic mass) and CT
scan (extrapelvic).
Secondary outcome
• Determination of PFS at 18 months in correlation with dominant genetic or
protein alterations
• Descriptive analysis of standard treatment modalities applied in
participating European countries
• Descriptive analysis of grade 3&4 treatment-associated side effects and
toxicities
• Descriptive analysis of molecular alterations frequency according to
geographic location.
Background summary
Cervical cancer is the second most common cause of cancer death in women
worldwide. Every year 270,000 women die from cervical cancer and another
500,000 are newly diagnosed.
Recent progress towards cervical cancer prevention was documented in a seminal
study using preventive anti HPV vaccines. Despite the enthusiasm with the
initial results of anti human papillomavirus (HPV) vaccination, it is generally
accepted that cervical cancer screening will have to continue, in particular
because the population most at risk will not have been vaccinated. Vaccination
is expected to impact incidence rates in more than 20 years from now when the
first vaccinated adolescents will have reached the age of developing cervical
cancer. Prior to that, patients who develop cervical cancer will not have been
vaccinated. We should also consider that the population *at risk* may not seek
vaccination for a variety of reasons. There is therefore a need today for the
improvement of CC medical practices in terms of diagnosis and treatment.
Furthermore, cervical cancer primarily affects younger women, with the majority
of cases appearing between the ages of 35 and 50, when many women are actively
involved in their career or caring for their families. The burden of cervical
cancer is particularly high in the new member states. The highest annual
world-standardized mortality rates are currently reported in Romania, Serbia
and Lithuania (11.4 - 9.2 and 10.0 /100 000, respectively) and the lowest rates
in Finland (1.1 /100 000) while average mortality rates in France, Germany and
The Netherlands are reported at 2.2- 2 and 1.7 /100 000, respectively.
Governmental authorities, parliamentary representatives should be aware that
the disparity of this public health problem in the east of the EU requires
special attention.
Study objective
Assess dominant mutations and activation pathways in cervical cancers
predictive to standard treatment response.
Study design
Prospective Multicentric European trial with tumour biopsies, and blood
collection for molecular analysis at predetermined time points.
Study burden and risks
Patients will have 1-5 time a biopsy and they will also give additional
bloodsamples (7x). This seems to be a mild load.
Biopsies of the cervix may cause mild vaginal bleeding, this usually stops
spontaneously. In some rare cases vaginal bleeding is severe and lead to a
short hospital stay for observation. Furthermore, there are no risks / side
effects to be expected.
Rue d'Ulm 25
Paris Cedex 05 75248
FR
Rue d'Ulm 25
Paris Cedex 05 75248
FR
Listed location countries
Age
Inclusion criteria
1)No prior treatment for cervical cancer.
2)FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type).
3)Pelvic MRI available or planned before the start of treatment if FIGO >= IB2, and optional for IB1 stage
4)Possibility to communicate imaging data by CD ROM (format DICOM 3.0 or more).
5)Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment).
6)Age >= 18 years.
7)ECOG 0-2.
8)Life expectancy > 6 months.
9)Patient eligible for standard treatment
10) Patient having health care insurance.
11) Informed and signed consent by patient.
Exclusion criteria
1)Patient enrolled in a clinical trial involving an investigative new agent.
2)Co morbidity, preventing patient to tolerate the proposed standard treatment.
3)Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix).
4)Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), if FIGO >= IB2.
5)Patient deprived from ability to decide on her own.
6)Patient unable to have a regular follow up for geographical, social or psychological reasons.
7)Pregnancy or patient old enough to procreate and not using effective contraceptive method.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43701.031.13 |