Oxford Ovarian Cancer Predict Chemotherapy Response 01

NCT ID: NCT01770535

Last Updated: 2013-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.

Detailed Description

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While paclitaxel is very effective in killing cancer cells in a proportion of patients, some patients don't respond to this treatment. As with any chemotherapy, paclitaxel is associated with unpleasant side effects. We are doing this study to try and understand what is happening in cancer cells in different individuals after paclitaxel treatment that make them respond differently to the same treatment. We hope that this study will enable us to develop a method to identify women who are suitable for this form of treatment. We also want to understand why some cancer cells don't get killed with paclitaxel. This information will help us to select treatment to suit an individual patient, and thus improve the outcome of treatment and avoid giving treatment that will not benefit the patient.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Female ≥ 18 years of age
* Newly diagnosed and histology confirmed primary high grade serous ovarian cancer, high grade serous fallopian tube cancer and primary peritoneal carcinoma.
* Radiological and laparoscopic confirmation of FIGO stage 3C or 4 ovarian cancer.
* Radiological evidence of omental or peritoneal deposits that are accessible for radiology-guided biopsy.
* At least one lesion on CT scan measuring at least 2 cm in maximum diameter performed in the past 31 days. Slightly older scans may be accepted at the discretion of the CI providing the results are considered to remain clinically relevant.
* Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
* Life expectancy of at least 6 months.
* The patient is willing and able to provide written informed consent and comply with the protocol for the duration of the study, and scheduled visits and examinations.
* Acceptable haematological and biochemical indices

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Churchill Hospital

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Ahmed A Ahmed

Role: CONTACT

Other Identifiers

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OXO-PCR-01

Identifier Type: -

Identifier Source: org_study_id

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