ClinicalTrials.gg
TerminatedNCT03466034Updated Jan 29, 2020

The Role of Hypoxia as a Selective Pressure for TP53 Mutations

An observational study in Endometrial Cancer, sponsored by Institute of Cancer Research, United Kingdom. Terminated at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-29.

Sponsored by Institute of Cancer Research, United Kingdom · Observational

Why this study was terminated
Low numbers of eligible patients and failure to successfully recruit them.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 111 studies in Endometrial Neoplasms with a site in United Kingdom — 29 open to participants now, 47 under way, 13 of them phase 3. Endometrial Neoplasms · United Kingdom.

Enrollment
22nd of 22
5 · median 163
Started
2018
with 5 others
Observational
22 of 111
4 open now
Registered
46th of 111
by date
Lead sponsor
3 of 111
Institute of Cancer Research, United Kingdom

Among the 111 studies in Endometrial Neoplasms with a site in United Kingdom, this one is the 22nd largest by enrollment of the 22 observational ones that give a count, is one of 6 that started in 2018, is one of 22 observational ones, and was the 46th registered.

Endometrial Neoplasms

1,426 studies on the registry are indexed under Endometrial Neoplasms; 471 are open to participants now.

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Open to participants now

29 of the 111 studies in Endometrial Neoplasms with a site in United Kingdom are open now. Recruiting first, the newest first:

24 more — sign in →

All 29 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 357 Endometrial Neoplasms studies recruiting now, 267 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 26 take children under 18; 23 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study summary

The study aims to develop scans that tell the investigators about the oxygen content of tumours using Magnetic Resonance Imaging (MRI) and seeing whether regions of low oxygen content are related to mutations in cancer genes such as TP53. MRI is a method of obtaining pictures of inside of the body that shows the appearance and structure of soft tissues.

To get the information about the oxygen content of tumours, MRI is carried out while breathing 100% oxygen. The variation of oxygen supply to different regions of the tumour will help the investigators to predict tumour behavior and tumour response to treatment.

Read the detailed description

Cancer tissue harbours a multitude of genetic alterations, and it is well-established that when certain key alterations develop, they are powerful determinants of tumour behaviour (growth rate, potential to spread). One of the most sinister and well-recognized alterations is in a gene called TP53. Another feature of tumours that results in resistance to treatment and poor outcome is a low oxygen level within tumour tissue. However, whether alterations in TP53 are driven by low oxygen levels is not established.

Endometrial cancer is a good model to study the relationship between low tumour oxygen levels and alterations in TP53 within tumour. Firstly, it is a common gynaecological malignancy, (9,300 new cases annually in the UK) with two recognized types based on the appearance and behaviour of the tumour. In type I (endometrioid and mucinous carcinomas), alterations in TP53 are uncommon (15%), while in type II (serous and clear cell carcinomas) they are common (88%). In-line with this, the survival of patients with Type 2 cancer is worse. Secondly, endometrial cancer is routinely assessed at diagnosis using Magnetic Resonance Imaging. This non-invasive scanning technique can be manipulated to derive additional information about the oxygen status of the whole tumour and regions within it. Finally, the primary management of endometrial cancer is surgical and involves hysterectomy. This means it is possible to obtain fresh tumour tissue at the time of surgery from regions that have been identified on imaging as having low vs.high levels of oxygen and to establish their TP53 status. In this study, therefore, the investigator will establish the regional oxygen distribution within endometrial cancers at diagnosis, and relate them to the alterations in TP53 from fresh tissue samples from selected regions using gene sequencing. Understanding how highly deleterious mutations arise in cancer might provide new avenues for intervention and control.

03

Conditions studied

  • Endometrial Cancer

Keywords

  • TP53
  • Hypoxia
  • Endometriod and Mucinous Carcinomas
  • Serous and Clear Cell Carcinomas
  • Magnetic Resonance Imaging, MRI
04

Who can participate

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

Study population

Participants scheduled to have hysterectomy at the cancer centre

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. ≥18 years of age on the day of signing the .
  2. confirmed endometroid or serous endometrial cancer.
  3. Scheduled to have hysterectomy at the cancer centre
  4. Identifiable tumour mass on staging MRI.
  5. Voluntarily agreed to participate by giving written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. of \< 6 months.
  2. Ferromagnetic implants, contraindicating MRI
  3. Claustrophobia so unable to tolerate MRI
  4. Unable to lie flat
  5. Ascites sufficient to prevent patient being fitted in the scanner bore
  6. Histology unlikely to show variation in TP53 status, or heavily calcified disease.
  7. Radiotherapy to the abdomen or pelvis within 6 months of the screening visit.
  8. Unresolved bowel obstruction.
  9. Currently participating or has participated in a study with an compound or device within 30 days of the start of treatment.
  10. History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
  11. Unlikely to comply with the requirements of the study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Endometriod

    Type I (endometrioid and mucinous carcinomas) - Magnetic Resonance Imaging (MRI) with 100% Oxygen.

  • Serous

    Type II (serous and clear cell carcinomas) - Magnetic Resonance Imaging (MRI) with 100% Oxygen.

06

What researchers measure

Primary outcomes

  1. Establish distinctive patterns of distribution and expression of mutant TP53 between tumour regions with differing levels of oxygenation (as measured by R2*on MRI).

    Determined at post surgery histology

    Time frame: Duration of study (24 months)

Secondary outcomes

  1. The reproducibility of the R2* measurement, assessed by comparing 2 R2* scans per person

    comparison of image data at conclusion of MRI scan

    Time frame: 6 months

  2. Establish the range of intratumoral heterogeneity of the R2* measurement within individual tumours

    comparison of image data at conclusion of MRI scan

    Time frame: 6 months

07

Study locations

1 site
  • The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
    Sutton, Surrey SM2 5PT, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Jun 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2018
First posted
Mar 15, 2018
StartActual
Feb 6, 2018
Primary completionActual
Jun 19, 2018
CompletionActual
Jul 30, 2019
Last update
Jan 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03466034
Collaborators
Cancer Research UK
Responsible party
Nandita deSouza (Professor, Institute of Cancer Research, United Kingdom) — Principal investigator
First posted
Mar 15, 2018
Start date
Feb 6, 2018
Primary completion
Jun 19, 2018
Completion
Jul 30, 2019
Last update
Jan 29, 2020

Study contacts

Nandita deSouza
principal investigator · The Institution of Cancer Research & The Royal Marsden NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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