Reproductive function in teenage and young adult cancer survivors
| ISRCTN | ISRCTN12061770 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12061770 |
| IRAS number | 285290 |
| Secondary identifying numbers | CPMS 49696, IRAS 285290 |
- Submission date
- 09/01/2023
- Registration date
- 03/03/2023
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
The treatment of cancer in young people is increasingly turning from focusing purely on survival to recognition of the long-term effects of treatment on subsequent quality of life. These issues are extremely important to patients and all involved in their care. In a recent UK research priority-setting initiative, research into the consequences of cancer was rated as a top priority by patients, their families, and healthcare professionals. That cancer treatment, including cytotoxic therapies, radiotherapy and surgery has adverse effects on fertility has long been recognised. In the ovary, chemotherapeutic agents affect growing follicles resulting in amenorrhea and in the longer-term loss of fertility and premature ovarian insufficiency (POI). For males, sperm counts can be very low after treatment, but in some there can be full or partial recovery.
Who can participate?
Any patient aged 13-25 years old with a new cancer diagnosis or presenting with a recurrence of cancer that requires treatment
What does the study involve?
A single blood sample and data collection are conducted at baseline, and 1-, 2- and 3-year follow-up. Where possible, the study visits will coincide with a clinical visit.
What are the possible benefits and risks of participating?
Patients will not benefit from participating in the study. As this is an observational study, no adverse events are expected. There is a risk of minor bruising after a blood sample is taken.
Where is the study run from?
University of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
January 2021 to January 2027
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Audrey Kuchnowski audrey.kuchnowski@ed.ac.uk (UK)
Contact information
Principal Investigator
Professor of Clinical Reproductive Science
Centre for Reproductive Health
Institute of Regeneration & Repair
University of Edinburgh
4-5 Little France Drive
Edinburgh
EH16 4UU
United Kingdom
 ORCID ID |
0000-0002-7495-518X |
|---|---|
| Phone | +44 (0) 131 242 2694 |
| richard.anderson@ed.ac.uk |
Public, Scientific
Centre for Reproductive Health
Institute of Regeneration & Repair
University of Edinburgh
4-5 Little France Drive
Edinburgh
EH16 4UU
United Kingdom
| Phone | +44 (0)131 242 2669 |
|---|---|
| audrey.kuchnowski@ed.ac.uk |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Laboratory, Medical and other records |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Reproductive function in teenage and young adult cancer patients in the UK |
| Study acronym | The PROTECT study |
| Study hypothesis | This study will undertake an analysis of the effects of cancer treatments on reproductive function in teenagers and young adults (TYA) to address the hypothesis that cancer diagnosis, cancer treatment and age at treatment affect fertility-related biomarkers and hence long-term fertility/reproductive health in survivors. This is a multi-centre clinical prospective observational cohort study open to clinical centres directly involved in the care of TYA (aged 13-25) with cancer. Previous studies are retrospective thus assessing historical treatments, and mostly rely on questionnaire-based self-reported outcomes, introducing the opportunity for bias and inaccuracy. Additionally, there is a need for data specific to this post-pubertal age group, distinct from children. |
| Ethics approval(s) | Approved 19/07/2021, South West - Frenchay Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square Bristol, BS1 6PN, UK; +44 (0)207 104 837; frenchay.rec@hra.nhs.uk), ref: 21/SW/0039 |
| Condition | Cancer and reproductive health |
| Intervention | This is a multi-centre clinical prospective observational cohort study open to all clinical centres directly involved in the care of teenage and young adults (aged 13-25) with cancer. Potentially eligible patients will be identified by the research team and/or clinical team looking after them. After an initial assessment, potentially eligible patients will be assessed for study inclusion by the assessing clinician and/or member of the research team. If the patient fulfils the study eligibility criteria and is deemed to be competent and have the capacity to consent, an appropriately delegated member of the study team will take written informed consent. It will be documented in the patient’s medical notes that they were deemed eligible and capable of providing written informed consent. There will be the option for parents/guardians to provide consent on behalf of those patients who are eligible and willing to take part in the study but are not capable of providing written informed consent. The study aims to recruit 1000 participants over a period of 5 years, approx. equally males and females. Participants’ demographics, clinical data including PMH, diagnosis information, treatment information and biological samples will be collected locally at study sites at the following timepoints: baseline, one year after diagnosis and annually thereafter for five years (in the first instance with the intention to extend follow-up). An additional blood sample will be obtained as part of the study to measure anti-Mullerian hormone (AMH) in serum (in females) and Inhibin B in serum (in males). These samples will be transported to the lead site (Edinburgh) for storage and analysis. This study is proposed in collaboration with the Teenage and Young Adult CSG of the National Cancer Research Institute (NCRI). The NCRI is a UK-wide partnership which promotes collaboration in cancer research. Study documentation will be reviewed by the Teenage and Young Adult group of the National Cancer Research Institute (NCRI). |
| Intervention type | Other |
| Primary outcome measure | Prevalence of reproductive failure and of gonadal dysfunction measured using diagnosis/treatment regimen at 2 years after diagnosis |
| Secondary outcome measures | Uptake of fertility preservation services, and long-term reproductive outcomes including ongoing ovulation/spermatogenesis, conception, age at menopause, and the need for hormone replacement. The prevalence of reproductive failure and of gonadal dysfunction by diagnosis/treatment regimen at 1 and 3 years after diagnosis. A blood sample is collected at baseline, and 1-, 2- and 3-year follow-up. In females, anti-Mullerian hormone (AMH) levels will be measured in serum, data will be analysed in conjunction with follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) levels. For males, Inhibin B will be measured in serum. Inhibin B data will be analysed in conjunction with FSH/LH/testosterone levels. |
| Overall study start date | 05/01/2021 |
| Overall study end date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 13 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1000; UK Sample Size: 1000 |
| Total final enrolment | 532 |
| Participant inclusion criteria | Current inclusion criteria as of 28/01/2025: 1. Willing and able to provide written informed consent (including by parent/guardian where appropriate) 2. Aged 13-25 years 3. First cancer diagnosis or relapse of same diagnosis 4. Requires cancer treatment with targeted, immunological and cell-based therapies (surgery, chemotherapy and radiotherapy are permitted if part of this treatment or if the initial treatment plan changes) Previous inclusion criteria: 1. Willing and able to provide written informed consent (including by parent/guardian where appropriate). 2. Aged 13-25 years old 3. First cancer diagnosis 4. Requires cancer treatment (surgery, chemotherapy including targeted therapies, radiotherapy, bone marrow transplant). |
| Participant exclusion criteria | 1. Inability to provide informed consent 2. Does not require cancer treatment 3. Where treatment is not given with the intention of cure or long-term survival |
| Recruitment start date | 28/01/2022 |
| Recruitment end date | 30/12/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Cambridge
CB2 0QQ
United Kingdom
Leeds
LS9 7TF
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Glasgow
G12 0XH
United Kingdom
Nottingham
NG7 2UH
United Kingdom
London
NW1 2PG
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
Brighton
BN2 5BE
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Exeter
EX2 5DW
United Kingdom
London
SW3 6JJ
United Kingdom
Sheffield
S10 2TH
United Kingdom
Sheffield
S5 7AU
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Southampton
SO16 6YD
United Kingdom
Bristol
BS2 8ED
United Kingdom
St Michaels Hill
Bristol
BS2 8BJ
United Kingdom
Cottingham
HU16 5JQ
United Kingdom
Headington
Oxford
OX3 7LE
United Kingdom
Plymouth
PL6 8DH
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Clarendon Wing
Great George Street
Leeds
LS1 3EX
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Edinburgh
Lothian
EH16 4TJ
United Kingdom
London
EC1A 7BE
United Kingdom
Glasgow
G12 0YN
United Kingdom
Manchester
M20 4BX
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Whitham Rd
Broomhall
Sheffield
S10 2SJ
United Kingdom
Sponsor information
Hospital/treatment centre
The Queen's Medical Research Institute
The University of Edinburgh
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 9447 |
|---|---|
| enquiries@accord.scot | |
| Website | http://www.ed.ac.uk/schools-departments/medicine-vet-medicine/about/little-france/qmri |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/01/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer reviewed journal 2. Presentation of the findings at reproductive medicine and cancer scientific meetings |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Anderson, including anonymised IPD, from credentialed academic researchers |
Editorial Notes
28/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2024 to 30/12/2024.
2. Total final enrolment added.
3. The inclusion criteria and contact details were updated.
09/01/2023: Trial's existence confirmed by the NIHR.
