Normal Risk Ovarian Screening Study : 21-Year Update
PURPOSE: The Normal Risk Ovarian Screening Study (NROSS) tested a two-stage screening strategy in postmenopausal women at conventional hereditary risk where significantly rising cancer antigen (CA)-125 prompted transvaginal sonography (TVS) and abnormal TVS prompted surgery to detect ovarian cancer.
METHODS: A total of 7,856 healthy postmenopausal women were screened annually for a total of 50,596 woman-years in a single-arm study (ClinicalTrials.gov identifier: NCT00539162). Serum CA125 was analyzed with the Risk of Ovarian Cancer Algorithm (ROCA) each year. If risk was unchanged and <1:2,000, women returned in a year. If risk increased above 1:500, TVS was undertaken immediately, and if risk was intermediate, CA125 was repeated in 3 months with a further increase in risk above 1:500 prompting referral for TVS. An average of 2% of participants were referred to TVS annually.
RESULTS: Thirty-four patients were referred for operations detecting 15 ovarian cancers and two borderline tumors with 12 in early stage (I-II). In addition, seven endometrial cancers were detected with six in stage I. As four ovarian cancers and two borderline tumors were diagnosed with a normal ROCA, the sensitivity for detecting ovarian and borderline cancer was 74% (17 of 23), and 70% of ROCA-detected cases (12 of 17) were in stage I-II. NROSS screening reduced late-stage (III-IV) disease by 34% compared with UKCTOCS controls and by 30% compared with US SEER values. The positive predictive value (PPV) was 50% (17 of 34) for detecting ovarian cancer and 74% (25 of 34) for any cancer, far exceeding the minimum acceptable study end point of 10% PPV.
CONCLUSION: While the NROSS trial was not powered to detect reduced mortality, the high specificity, PPV, and marked stage shift support further development of this strategy.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:42 |
|---|---|
| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 42(2024), 10 vom: 01. März, Seite 1102-1109 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Han, Chae Young [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
|---|
| Anmerkungen: |
Date Completed 29.03.2024 Date Revised 29.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT00539162 Citation Status MEDLINE |
|---|
| doi: |
10.1200/JCO.23.00141 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM366852132 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM366852132 | ||
| 003 | DE-627 | ||
| 005 | 20240330000735.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240114s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1200/JCO.23.00141 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1355.xml |
| 035 | |a (DE-627)NLM366852132 | ||
| 035 | |a (NLM)38194613 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Han, Chae Young |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Normal Risk Ovarian Screening Study |b 21-Year Update |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 29.03.2024 | ||
| 500 | |a Date Revised 29.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00539162 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: The Normal Risk Ovarian Screening Study (NROSS) tested a two-stage screening strategy in postmenopausal women at conventional hereditary risk where significantly rising cancer antigen (CA)-125 prompted transvaginal sonography (TVS) and abnormal TVS prompted surgery to detect ovarian cancer | ||
| 520 | |a METHODS: A total of 7,856 healthy postmenopausal women were screened annually for a total of 50,596 woman-years in a single-arm study (ClinicalTrials.gov identifier: NCT00539162). Serum CA125 was analyzed with the Risk of Ovarian Cancer Algorithm (ROCA) each year. If risk was unchanged and <1:2,000, women returned in a year. If risk increased above 1:500, TVS was undertaken immediately, and if risk was intermediate, CA125 was repeated in 3 months with a further increase in risk above 1:500 prompting referral for TVS. An average of 2% of participants were referred to TVS annually | ||
| 520 | |a RESULTS: Thirty-four patients were referred for operations detecting 15 ovarian cancers and two borderline tumors with 12 in early stage (I-II). In addition, seven endometrial cancers were detected with six in stage I. As four ovarian cancers and two borderline tumors were diagnosed with a normal ROCA, the sensitivity for detecting ovarian and borderline cancer was 74% (17 of 23), and 70% of ROCA-detected cases (12 of 17) were in stage I-II. NROSS screening reduced late-stage (III-IV) disease by 34% compared with UKCTOCS controls and by 30% compared with US SEER values. The positive predictive value (PPV) was 50% (17 of 34) for detecting ovarian cancer and 74% (25 of 34) for any cancer, far exceeding the minimum acceptable study end point of 10% PPV | ||
| 520 | |a CONCLUSION: While the NROSS trial was not powered to detect reduced mortality, the high specificity, PPV, and marked stage shift support further development of this strategy | ||
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a CA-125 Antigen |2 NLM | |
| 700 | 1 | |a Lu, Karen H |e verfasserin |4 aut | |
| 700 | 1 | |a Corrigan, Gwen |e verfasserin |4 aut | |
| 700 | 1 | |a Perez, Alexandra |e verfasserin |4 aut | |
| 700 | 1 | |a Kohring, Sharlene D |e verfasserin |4 aut | |
| 700 | 1 | |a Celestino, Joseph |e verfasserin |4 aut | |
| 700 | 1 | |a Bedi, Deepak |e verfasserin |4 aut | |
| 700 | 1 | |a Bedia, Enrique |e verfasserin |4 aut | |
| 700 | 1 | |a Bevers, Therese |e verfasserin |4 aut | |
| 700 | 1 | |a Boruta, David |e verfasserin |4 aut | |
| 700 | 1 | |a Carlson, Matthew |e verfasserin |4 aut | |
| 700 | 1 | |a Holman, Laura |e verfasserin |4 aut | |
| 700 | 1 | |a Leeds, Leroy |e verfasserin |4 aut | |
| 700 | 1 | |a Mathews, Cara |e verfasserin |4 aut | |
| 700 | 1 | |a McCann, Georgia |e verfasserin |4 aut | |
| 700 | 1 | |a Moore, Richard G |e verfasserin |4 aut | |
| 700 | 1 | |a Schlumbrecht, Matthew |e verfasserin |4 aut | |
| 700 | 1 | |a Slomovitz, Brian |e verfasserin |4 aut | |
| 700 | 1 | |a Tobias, Dan |e verfasserin |4 aut | |
| 700 | 1 | |a Williams-Brown, Yvette |e verfasserin |4 aut | |
| 700 | 1 | |a Bevers, Michael W |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Jinsong |e verfasserin |4 aut | |
| 700 | 1 | |a Gornet, Terrie G |e verfasserin |4 aut | |
| 700 | 1 | |a Handy, Beverly C |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Zhen |e verfasserin |4 aut | |
| 700 | 1 | |a Bedia, Jacob S |e verfasserin |4 aut | |
| 700 | 1 | |a Skates, Steven J |e verfasserin |4 aut | |
| 700 | 1 | |a Bast, Robert C |c Jr |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of clinical oncology : official journal of the American Society of Clinical Oncology |d 1986 |g 42(2024), 10 vom: 01. März, Seite 1102-1109 |w (DE-627)NLM012608777 |x 1527-7755 |7 nnns |
| 773 | 1 | 8 | |g volume:42 |g year:2024 |g number:10 |g day:01 |g month:03 |g pages:1102-1109 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1200/JCO.23.00141 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 42 |j 2024 |e 10 |b 01 |c 03 |h 1102-1109 | ||