Summary
Background: The current screening methods for cervical cancer screening among women living with HIV (WLHIV) have previously shown high sensitivity but poor specificity for the detection of high-grade cervical intraepithelial neoplasia (CIN2+), resulting in over-referral for colposcopy and overtreatment of cervical lesions that may have low potential for progression to cancer. Methylation changes of human genes or HPV DNA have been reported early in carcinogenesis but their validation for predicting CIN among WLHIV is lacking.
Objectives: Among 1238 WLHIV enrolled in Burkina Faso (BF; n=615) and South Africa (SA; n=623), the MesHH study aims to evaluate the performance of the DNA methylation of human genes (CADM1, MAL, MiR and EPB41L3) and HPV (HPV16/18/31/33) for the detection of prevalent and incident CIN2+ compared to, or in combination with, other screening methods (visual inspection using acetic acid [VIA] or Lugol’s iodine [VILI], cytology and HPV DNA) and to evaluate the capacity of the DNA methylation markers to distinguish cervical lesion progression, persistence or regression at 16 months follow-up.
Methods: The study will use endocervical swabs with matching histological data collected as part of a prospective study evaluating cervical cancer screening strategies among WLHIV in BF and SA. The DNA methylation assays for human genes (CADM1, MAL, MiR, EPB41L3) and HPV (HPV16/18/31/33) will be performed using pyrosequencing assays. Sensitivity, specificity, positive and negative predictive values for the detection of CIN2+ will be estimated for the various DNA methylation markers, as stand-alone or multiplex tests.
Relevance: Multiplex DNA methylation assays including a combination of human genes and HPV virus may have potential as primary screening for CIN2+ among WLHIV. DNA methylation assays also have the potential to be performed using the same clinician- or self-collected sample used for cytology or HPV testing, thereby increasing screening coverage.
Objectives: Among 1238 WLHIV enrolled in Burkina Faso (BF; n=615) and South Africa (SA; n=623), the MesHH study aims to evaluate the performance of the DNA methylation of human genes (CADM1, MAL, MiR and EPB41L3) and HPV (HPV16/18/31/33) for the detection of prevalent and incident CIN2+ compared to, or in combination with, other screening methods (visual inspection using acetic acid [VIA] or Lugol’s iodine [VILI], cytology and HPV DNA) and to evaluate the capacity of the DNA methylation markers to distinguish cervical lesion progression, persistence or regression at 16 months follow-up.
Methods: The study will use endocervical swabs with matching histological data collected as part of a prospective study evaluating cervical cancer screening strategies among WLHIV in BF and SA. The DNA methylation assays for human genes (CADM1, MAL, MiR, EPB41L3) and HPV (HPV16/18/31/33) will be performed using pyrosequencing assays. Sensitivity, specificity, positive and negative predictive values for the detection of CIN2+ will be estimated for the various DNA methylation markers, as stand-alone or multiplex tests.
Relevance: Multiplex DNA methylation assays including a combination of human genes and HPV virus may have potential as primary screening for CIN2+ among WLHIV. DNA methylation assays also have the potential to be performed using the same clinician- or self-collected sample used for cytology or HPV testing, thereby increasing screening coverage.
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| Web resources: | https://cordis.europa.eu/project/id/796581 |
| Start date: | 05-09-2018 |
| End date: | 04-09-2020 |
| Total budget - Public funding: | 158 121,60 Euro - 158 121,00 Euro |
Cordis data
Original description
Background: The current screening methods for cervical cancer screening among women living with HIV (WLHIV) have previously shown high sensitivity but poor specificity for the detection of high-grade cervical intraepithelial neoplasia (CIN2+), resulting in over-referral for colposcopy and overtreatment of cervical lesions that may have low potential for progression to cancer. Methylation changes of human genes or HPV DNA have been reported early in carcinogenesis but their validation for predicting CIN among WLHIV is lacking.Objectives: Among 1238 WLHIV enrolled in Burkina Faso (BF; n=615) and South Africa (SA; n=623), the MesHH study aims to evaluate the performance of the DNA methylation of human genes (CADM1, MAL, MiR and EPB41L3) and HPV (HPV16/18/31/33) for the detection of prevalent and incident CIN2+ compared to, or in combination with, other screening methods (visual inspection using acetic acid [VIA] or Lugol’s iodine [VILI], cytology and HPV DNA) and to evaluate the capacity of the DNA methylation markers to distinguish cervical lesion progression, persistence or regression at 16 months follow-up.
Methods: The study will use endocervical swabs with matching histological data collected as part of a prospective study evaluating cervical cancer screening strategies among WLHIV in BF and SA. The DNA methylation assays for human genes (CADM1, MAL, MiR, EPB41L3) and HPV (HPV16/18/31/33) will be performed using pyrosequencing assays. Sensitivity, specificity, positive and negative predictive values for the detection of CIN2+ will be estimated for the various DNA methylation markers, as stand-alone or multiplex tests.
Relevance: Multiplex DNA methylation assays including a combination of human genes and HPV virus may have potential as primary screening for CIN2+ among WLHIV. DNA methylation assays also have the potential to be performed using the same clinician- or self-collected sample used for cytology or HPV testing, thereby increasing screening coverage.
Status
CLOSEDCall topic
MSCA-IF-2017Update Date
28-04-2024
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