Overview

Signal Transduction Analysis in OVarian cancER

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
Female

Summary

PROBLEM DEFINITION/OBJECTIVE: Ovarian cancer is the 5th most lethal cancer in the world due to the fact that tumours are detected at late stage of disease, currently without curative therapies at that stage. Standard therapy consists of surgery and chemotherapy. Despite this aggressive treatment overall five year survival is only 30%. Tumors are driven by cellular signal transduction (ST) pathways. Identifying activity of these pathways in cancer tissue can be used to choose an appropriate targeted drug. A number of targeted therapy drugs have become available, or are being developed that target individual ST pathways. Identification of the predominant ST pathway in cancer has shown to be extremely difficult. A newly developed reliable mRNA analysis technique (STAnalysis) is able to assess which pathway/s is/are active indicating which targeted therapy is deemed to be effective. STUDY DESIGN: A multicentre prospective cohort study. STUDY POPULATION: Patients with platinum-refractory/resistant or recurrent ovarian cancer. DIAGNOSTIC INTERVENTION & COMPARATOR: Analysis of the prevalent ST pathway and targeted therapy towards this pathway. OUTCOME MEASURES: Increase in survival.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Gynaecologisch Oncologisch Centrum Zuid

Collaborators:

Erasmus Medical Center
Radboud University

Treatments:

Hydroxyitraconazole
Itraconazole
Tamoxifen

Criteria

Inclusion Criteria:

- Female, age > 18 years

- Proven recurrence of FIGO stage III-IV ovarian carcinoma

- Ability and willingness to provide written and oral consent

- Able to speak and understand Dutch

- Physical condition WHO 0 or I

Exclusion Criteria:

- Age < 18 years

- Final diagnosis not ovarian carcinoma

- Chemotherapy naive

- Unable or unwilling to provide informed consent

- Enrolled in hospice or palliative care