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Status unknownNCT01770535OXO-PCR-01Updated Jan 17, 2013

Oxford Ovarian Cancer Predict Chemotherapy Response 01

An observational study in Ovarian Cancer, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-17.

Sponsored by University of Oxford · Observational

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
35
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Ovarian Cancer

Keywords

  • Ovarian cancer, paclitaxel
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 35 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with radiological and histological evidence of advanced ovarian cancer, who would standardly be managed by primary chemotherapy and interval debulking surgery

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

Exclusion Criteria:

-

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment

    Correlation between βIII tubulin expression and Mitotic Index (MI) before and after single agent paclitaxel treatment to determine whether overexpression of βIII tubulin is associated with Paclitaxel resistance

    Time frame: Before and 24-hours after paclitaxel treatment

Secondary outcomes

  1. Correlation between mitotic index and the magnitude of CA125 response

    Correlation between mitotic index and the magnitude of CA125 response will be analysed to investigate whether post-paclitaxel mitotic index is a determinant of clinical response in ovarian cancer

    Time frame: three weeks after paclitaxel treatment

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Study locations

1 of 1 sites recruiting
  • Churchill Hospital
    Oxford, United Kingdom
    • Ahmed A Ahmed · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01770535
Lead sponsor
University of Oxford
Responsible party
Sponsor
First posted
Jan 17, 2013
Start date
Nov 2012
Primary completion
Dec 2014 (estimated)
Completion
Jun 2015 (estimated)
Last update
Jan 17, 2013

Study contacts

Ahmed A Ahmed
Contact
ahmed.ahmed@obs-gyn.ox.ac.uk

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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