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Study FH01: Evaluation of mammographic surveillance services in women under 50 with a family history of breast cancer

The FH01, or ‘Evaluation of mammographic surveillance services in women under 50 with a family history of breast cancer’, study is trying to find out whether yearly mammograms in women aged 40 to 49 who are at an increased risk of developing breast cancer do save lives.
The NHS Breast Screening Programme currently offers mammography to women over the age of 50. Recently the National Institute for Health and Clinical Excellence (NICE) Familial Breast Cancer clinical guideline recommended that women with a moderate or strong family history of breast cancer should be offered annual mammography between the ages of 40 and 49. Although this recommendation is based on the best existing evidence, health professionals still need to know more about how effective this screening is.

What is the FH01 study?

The FH01, or ‘Evaluation of mammographic surveillance services in women under 50 with a family history of breast cancer’, study is trying to find out whether yearly mammograms in women aged 40 to 49 who are at an increased risk of developing breast cancer do save lives. It is being performed by Dr James Mackay, supported by Cancer Research UK and the NHS Research and Development Health Technology Assessment Programme.

What is the aim of the study?

Mammographic screening aims to detect breast cancer early, at a stage when treatment may be more successful. By monitoring women with a significant family history who are offered annual mammography, researchers aim to determine:

  • If breast cancers are diagnosed earlier because of screening and if earlier diagnosis of these breast cancers means that they are more easily and effectively treated.
  • The cost-effectiveness of regular mammography in this group of women.
  • Who do we need to participate?

This study needs women with a significant family history of breast cancer who are over 40 but less than 45 and are offered annual mammography to take part. Women will not be able to take part if:

  • They are unable to give written informed consent.
  • They are pregnant.
  • They are under 40.
  • They have had breast cancer or ductal carcinoma in situ.
  • They have had bilateral prophylactic mastectomy.
  • Women who are already attending a family history clinic and having mammography can join the study.

How will the study work?

If you agree to join, then your GP or your hospital consultant can refer you to your local genetics or family history clinic to enter the study. The genetics or family history clinic will help you to enrol. To do this they will make sure that they have the correct details about your family history, previous mammographic screening history and results, and any treatment you have had following on from screening. You will be asked to sign consent forms to participate in the study and to allow the information that you provide to be stored on the central study database at Breast Test Wales in Cardiff.

All data you provide will be confidential and will be anonymised before analysis. We hope that your participation will help health professionals work out how widely annual mammography should be offered in the future.

If I am interested in taking part who should I contact?

You should contact your GP or hospital consultant if you are happy to take part. They will put you in touch with the appropriate person at your local genetics or family history clinic.

If you would like more information about the FH01 study first, then please contact Sue Thomas, the Study Co-ordinator on 02920 787877.

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