ObesityDEPISGYNNCT04357652
Contraception and Cervical and Breast Cancer Screening in Obese Versus Non-obese Women
An observational study of Obesity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
.Brief Summary:* Obesity is a major public health problem in France. Indeed, 17% of the French population is obese (BMI greater than or equal to 30 kg/m²) while almost half of the adult population is overweight (BMI greater than or equal to 25 kg/m²). Read more about this study
- Who is it for?
- Ages 25 to 74 years
- Conditions the study is for
- Obesity
- How many people
- 439 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All women between 25 and 74 years old, who have a consultation at the CHU of Montpellier in endocrinology and/or in metabolic surgery and/or in a general practice in Occitania for a period of 6 months.
Who may be able to join
- women from 25 to 74 years old
- BMI ≥ 18,5
- agree to participate in the study when they consult their endocrinologist or general practitioner.
Who cannot join
- Subject opposition
- Subject in guardianship or trusteeship
- Women < 25 years of age and > 74 years of age
- Women with a BMI < 18.5 kg/m2
- Women with a history of breast or cervical cancer or hysterectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contraception and Cervical and Breast Cancer Screening in Obese Versus Non-obese Women Aged 25 to 74 Years Old
.Brief Summary:* Obesity is a major public health problem in France. Indeed, 17% of the French population is obese (BMI greater than or equal to 30 kg/m²) while almost half of the adult population is overweight (BMI greater than or equal to 25 kg/m²).
There is an increased risk of gynecological cancer in obese women but screening is less often performed :
Read more
In women, obesity is a risk factor for the occurrence of certain cancers such as uterine cancer, epithelial ovarian cancer and breast cancer, particularly post-menopausal. In addition, an increase in BMI from the first stage of obesity is associated with larger breast tumors with more frequent lymph node involvement, indicating more invasive cancers. Recent studies have shown an increase in breast cancer mortality for women with grade 2 and 3 obesity compared to women of so-called normal weight. Mortality from invasive breast cancer is higher from the obesity stage onwards.
The current recommendations of the High Authority for Health recommend breast cancer screening by mammography and clinical examination every two years in all women aged 50 to 74, excluding women at high risk and requiring specialist follow-up. Organized screening for cervical cancer has recently been modified. From 25 to 30 years of age the modalities remain the same and consist of two cytological examinations one year apart and then every 3 years if the latest results are normal. From the age of 30 and up to the age of 65, it is now recommended that an HPV test be performed as a first-line test, 3 years after the last normal cytological examination and then every 5 years if the last test was negative.
Studies dating back quite some time had shown an under-screening of cancers in obese women, in terms of carrying out mammography and cervical smears compared to women of normal weight. More recent data on access to gynecological cancer screening for obese women are heterogeneous, but there still seems to be less access to these examinations, whether for mammography or cervical smears. For example, a large American cohort study observed poorer detection of pre-cancerous lesions by smear with increasing BMI. Obese women had the lowest cumulative risk of pre-cancerous lesions at five years (followed by overweight women), but the highest rate of cancer at five years, associated with higher mortality.
A neglected contraception in obese women?
Data in the literature show that rates of unintended and unplanned pregnancies are higher in obese women (mainly those with grade 3 obesity) than in normal-weight women. This is associated with a lower use of contraception which is certainly poly-factorial: contraception not necessary due to a decrease in fertility linked to obesity, increased risks linked to contraception in obese women... However, most current contraceptive methods have shown similar efficacy in obese and non-obese women.
This context suggests that there is still a marked difference in the gynecological management of obese women. The role of the general practitioner seems essential in this follow-up by facilitating the use of screening tests and by improving the information of this population with regard to contraception in particular.
The objective of this study is to compare the gynecological follow-up of obese and non-obese women in a sample of women in Occitania, in terms of screening for breast and cervical cancer, as well as in terms of access to a method of contraception in general practice.
- Conditions
- Obesity
- Keywords
- breast cancer, cervical cancer, contraception, screening
- Medical subject headings
- Obesity, Breast Neoplasms, Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mammography screening
Rate of mammography screening in the previous two years among 50-74 year olds
Measured: 1 day
Rate of screening by Pap smear or HPV test
Rate of screening by Pap smear or HPV test in the previous three years for 25-65 year olds.
Measured: 1 day
Secondary outcomes (1)
Rate of contraceptive prescriptions
Rate of contraceptive prescriptions among women aged 25 to 50.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Jun 2020
- Primary completion1 Apr 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariane SULTAN, PR, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357652
- Sponsor's protocol ID
- RECHMPL20_0130
- Acronym
- DEPISGYN
- Status last verified
- Sep 2022
- First submitted
- 19 Apr 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Foucault E, Macioce V, Soler M, Pers YM, Bonnet JB, Avignon A, Chevalier N, Sultan A. Adherence to breast and cervical cancer screening guidelines according to obesity status: a French cross-sectional multicenter survey. Prev Med Rep. 2026 Feb 9;63:103405. doi: 10.1016/j.pmedr.2026.103405. eCollection 2026 Mar.
PubMed 41732746
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraception and Cervical and Breast Cancer Screening in Obese Versus Non-obese Women Aged 25 to 74 Years Old
- ClinicalTrials.gov ID
- NCT04357652
- Acronym / sponsor ID
- DEPISGYN / RECHMPL20_0130
- Conditions
- Obesity
- Keywords
- breast cancer, cervical cancer, contraception, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
.Brief Summary:* Obesity is a major public health problem in France. Indeed, 17% of the French population is obese (BMI greater than or equal to 30 kg/m²) while almost half of the adult population is overweight (BMI greater than or equal to 25 kg/m²).
There is an increased risk of gynecological cancer in obese women but screening is less often performed :
In women, obesity is a risk factor for the occurrence of certain cancers such as uterine cancer, epithelial ovarian cancer and breast cancer, particularly post-menopausal. In addition, an increase in BMI from the first stage of obesity is associated with larger breast tumors with more frequent lymph node involvement, indicating more invasive cancers. Recent studies have shown an increase in breast cancer mortality for women with grade 2 and 3 obesity compared to women of so-called normal weight. Mortality from invasive breast cancer is higher from the obesity stage onwards.
The current recommendations of the High Authority for Health recommend breast cancer screening by mammography and clinical examination every two years in all women aged 50 to 74, excluding women at high risk and requiring specialist follow-up. Organized screening for cervical cancer has recently been modified. From 25 to 30 years of age the modalities remain the same and consist of two cytological examinations one year apart and then every 3 years if the latest results are normal. From the age of 30 and up to the age of 65, it is now recommended that an HPV test be performed as a first-line test, 3 years after the last normal cytological examination and then every 5 years if the last test was negative.
Studies dating back quite some time had shown an under-screening of cancers in obese women, in terms of carrying out mammography and cervical smears compared to women of normal weight. More recent data on access to gynecological cancer screening for obese women are heterogeneous, but there still seems to be less access to these examinations, whether for mammography or cervical smears. For example, a large American cohort study observed poorer detection of pre-cancerous lesions by smear with increasing BMI. Obese women had the lowest cumulative risk of pre-cancerous lesions at five years (followed by overweight women), but the highest rate of cancer at five years, associated with higher mortality.
A neglected contraception in obese women?
Data in the literature show that rates of unintended and unplanned pregnancies are higher in obese women (mainly those with grade 3 obesity) than in normal-weight women. This is associated with a lower use of contraception which is certainly poly-factorial: contraception not necessary due to a decrease in fertility linked to obesity, increased risks linked to contraception in obese women... However, most current contraceptive methods have shown similar efficacy in obese and non-obese women.
This context suggests that there is still a marked difference in the gynecological management of obese women. The role of the general practitioner seems essential in this follow-up by facilitating the use of screening tests and by improving the information of this population with regard to contraception in particular.
The objective of this study is to compare the gynecological follow-up of obese and non-obese women in a sample of women in Occitania, in terms of screening for breast and cervical cancer, as well as in terms of access to a method of contraception in general practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women between 25 and 74 years old, who have a consultation at the CHU of Montpellier in endocrinology and/or in metabolic surgery and/or in a general practice in Occitania for a period of 6 months.
Key inclusion criteria (3 listed)
- women from 25 to 74 years old
- BMI ≥ 18,5
- agree to participate in the study when they consult their endocrinologist or general practitioner.
Key exclusion criteria (5 listed)
- Subject opposition
- Subject in guardianship or trusteeship
- Women < 25 years of age and > 74 years of age
- Women with a BMI < 18.5 kg/m2
- Women with a history of breast or cervical cancer or hysterectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of mammography screening
Time frame: 1 day
Rate of mammography screening in the previous two years among 50-74 year olds
Rate of screening by Pap smear or HPV test
Time frame: 1 day
Rate of screening by Pap smear or HPV test in the previous three years for 25-65 year olds.
1 secondary outcome
Rate of contraceptive prescriptions
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Derived from this study: PubMed 41732746Foucault E, Macioce V, Soler M, Pers YM, Bonnet JB, Avignon A, Chevalier N, Sultan A. Adherence to breast and cervical cancer screening guidelines according to obesity status: a French cross-sectional multicenter survey. Prev Med Rep. 2026 Feb 9;63:103405. doi: 10.1016/j.pmedr.2026.103405. eCollection 2026 Mar.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariane SULTAN, PR study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mammography screening (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.