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Contact Information:

Dr Patricia Roxburgh
+44 (0)1413017000
Patricia.Roxburgh@glasgow.ac.uk


Ms Karen Allan
+44 141 301 7959
karen.allan.3@glasgow.ac.uk


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Be Part of Research - Trial Details - A study to characterise mechanisms of resistance to PARP inhibitors by analysing samples from women with ovarian cancer
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A study to characterise mechanisms of resistance to PARP inhibitors by analysing samples from women with ovarian cancer

Recruiting

Open to: Female

Age: Adult

Glasgow

Medical Conditions

High-grade ovarian cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.



Background and study aims
PARP inhibitors are a type of targeted cancer drug. The aim of this study is to collect tumour samples from women who are treated with PARP inhibitors and then analyse them to help us understand why some women benefit from PARP inhibitor therapy while others do not. This would enable us to use PARP inhibitors in the future in a more personalised way, sparing patients unlikely to benefit from the side effects of PARP inhibitors while ensuring those who will benefit receive PARP inhibition therapy.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

26 Jul 2022 01 May 2025

This is a sample collection study. Access to participants' archival pre-PARP inhibitor tumour sample will be requested. Blood samples will be taken from participants, alongside their routine blood tests. A biopsy (sample) will be taken if a participant's cancer gets worse during treatment with a PARP inhibitor. Clinical information about participants' cancer will be recorded. The samples will be examined in the laboratory to learn more about markers that predict sensitivity and resistance to PARP inhibitor treatment.


Patients aged 16 years and over with a diagnosis of high-grade serous, high-grade endometrioid or carcinosarcoma of the ovary, primary peritoneum or fallopian tube. Trial participants must have an available archival tissue sample from the time of their original diagnosis. They must have had prior treatment with a PARP inhibitor or be about to start maintenance treatment with a PARP inhibitor.

You can take part if:


Current inclusion criteria as of 07/04/2025:
All patients:
1. Age ≥16 years
2. Histological diagnosis of high-grade serous, high-grade endometrioid or carcinosarcoma of the ovary, primary peritoneum or fallopian tube
3. Availability of formalin-fixed, paraffin-embedded tissue taken at the time of original diagnosis of high-grade serous ovarian cancer. This may be primary surgical debulking specimen OR core biopsy. For those with only a core biopsy from time of diagnosis, availability of specimen taken at interval debulking surgery is also requested.
4. Prior treatment with a PARP inhibitor or about to commence maintenance PARPi therapy (cohort A). PARPi can be single agent or in combination with bevacizumab. If PARPi is in combination with a different agent as part of a clinical trial, the patient may still be eligible but this should be confirmed with the Cancer Research UK Glasgow Clinical Trials Unit prior to patient registration.

Cohort A:
1. Patients need to be progression-free (defined by no evidence of GCIG Ca125 progression or radiological progression)
2. No contraindication to biopsy
3. Ability to provide written informed consent prior to participating in the study and any study-related procedures being performed
4. Willingness to comply with trial procedures
5. Life expectancy >3 months
6. About to commence, currently receiving PARPi as maintenance therapy or completed PARPi maintenance with no intervening treatment before study entry.

Cohort B:
1. Patients need to have radiologically defined progressive disease on PARPi
2. Patients must have disease deemed suitable for imaging-guided biopsy (ultrasound or CT) by an experienced radiologist or suitable for intra-operative biopsy during secondary debulking surgery as determined by an experienced gynaecological oncology surgeon. Other biopsies, such as skin deposits, are also acceptable. However, this must be confirmed with the Cancer Research UK Glasgow Clinical Trials Unit prior to patient registration (for cohort B).
3. No contraindication to biopsy
4. No systemic anti-cancer treatment (SACT) commenced post PARPi (patients continuing PARPi after surgical resection of a progressing lesion can be included). Patients who have received 1-2 cycles of SACT whilst awaiting surgery may still be eligible for the study, please contact CTU to discuss prior to registration.
5. Ability to provide written informed consent prior to participating in the study and any study-related procedures being performed
6. Willingness to comply with trial procedures
7. Life expectancy >3 months

Cohort C:
1. Patients need to have had a lesion which radiologically progressed on PARPi
2. Archival tumour of a lesion progressing post PARPi must be available
3. Ability to provide written informed consent prior to participating in the study and any study-related procedures being performed. Patients with available archival pre and post-PARPi tumour samples, who are no longer living may be identified by their clinical team and registered for the


You may not be able to take part if:


Current exclusion criteria as of 07/04/2025:1. Ovarian, primary peritoneal or fallopian tube cancer of low-grade serous, grades 1 or 2 endometrioid, clear cell or mucinous subtypes2. Borderline/low malignant potential tumours3. Any non-epithelial ovarian malignancy4. Original diagnosis of high-grade serous cancer made on cytology only5. Discontinued PARPi for toxicity within 3 months of starting PARPi. (exclusion applies to cohorts B & C only). Patients who are recruited to cohort A at initiation of PARPi and subsequently discontinue within 3 months for toxicity will be replaced. Cohort A patients who progress and discontinue PARPi within 3 months will be included in the analysis and will not be replaced 6. Any other severe concurrent disease which may increase the risk associated with trial participation7. Any psychological, familial, sociological or geographical considerations potentially hampering compliance with the trial and follow-up schedule

Previous exclusion criteria:1. Ovarian, primary peritoneal or fallopian tube cancer of low-grade serous, grades 1 or 2 endometrioid, clear cell or mucinous subtypes2. Borderline/low malignant potential tumours3. Any non-epithelial ovarian malignancy4. Original diagnosis of high-grade serous cancer made on cytology only5. Discontinued PARPi for toxicity within 3 months of starting PARPi6. Any other severe concurrent disease which may increase the risk associated with trial participation7. Any psychological, familial, sociological or geographical considerations potentially hampering compliance with the trial and follow-up schedule


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Beatson West of Scotland Cancer Centre
    1053 Great Western Road
    Glasgow
    G12 0YN

There is no direct medical benefit to participants. Women diagnosed with ovarian cancer in the future will benefit from an increased understanding of sensitivity and resistance to PARP inhibitors. This increased understanding should spare women who are unlikely to benefit from PARP inhibitor treatment from the side effects of a PARP inhibitor and develop alternative treatments for those unlikely to benefit and for those who develop resistance to PARP inhibitors.
Participants having a biopsy may suffer from side effects. In general they may have bruising, pain and/or infection at the biopsy site. In order to minimise pain, local anaesthetic may be given prior to the biopsy procedure and painkillers may be prescribed afterwards. If an infection develops, it may require treatment with antibiotics. The risk of infection is estimated to be less than 1 in 100. In very rare cases, biopsy-associated bleeding may require a blood transfusion and/or intervention (radiological or surgical). Other adverse events due to a biopsy will depend on the location the biopsy is taken from. For example, if a lung biopsy is undertaken there would be a risk of pneumothorax (air around the outside of the lung which can sometimes cause shortness of breath). If CT guidance is used, there is a risk of allergic reaction to the contrast given to a patient before the CT to achieve good quality images. In rare cases, patients can suffer from renal impairment as a result of contrast. This CT would be extra to those that participants would have if they did not take part in this study. This procedure uses ionising radiation to form images of the body to aid biopsy. Ionising radiation can cause cell damage that may after many years or decades turn cancerous. In patients with the clinical condition being investigated, the chance of this happening is extremely small.

Ms Karen Allan
+44 141 301 7959
karen.allan.3@glasgow.ac.uk


Dr Patricia Roxburgh
+44 (0)1413017000
Patricia.Roxburgh@glasgow.ac.uk



The study is sponsored by NHS Greater Glasgow and Clyde and funded by Wellbeing of Women; Artios Pharma Company Ltd.



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Read full details for Trial ID: ISRCTN59698923

Or CPMS 51118

Last updated 07 April 2025

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