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Open Access 03-02-2025 | Gynecologic Cancer | Original Paper

Determinants of first-line clinical trial enrollment among Black and White gynecologic cancer patients

Authors: Autumn B. Carey, Caitlin E. Meade, Britton Trabert, Casey M. Cosgrove, Ashley S. Felix

Published in: Cancer Causes & Control

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Abstract

Purpose

Disparities in gynecologic cancer clinical trial enrollment exist between Black and White patients; however, few examine racial differences in clinical trial enrollment predictors. We examined whether first-line clinical trial enrollment determinants differed between Black and White gynecologic cancer patients.

Methods

We used the National Cancer Database to identify Black and White gynecologic cancer (cervix, ovarian, uterine) patients diagnosed in 2014–2020. Multivariable logistic regression was used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for associations between clinical trial enrollment (yes vs no) and sociodemographic, facility, tumor, and treatment characteristics stratified by race. We included a multiplicative interaction term between each assessed predictor and race to test whether associations differed by race.

Results

We included 703,022 gynecologic cancer patients (mean [SD] age at diagnosis, 60.9 [13.1] years). Clinical trial enrollment was lower among Black (49/86,058, 0.06%) vs. White patients (710/616,964, 0.11%). Only cancer site differed by race: among Black patients, a cervical vs. uterine cancer diagnosis (OR = 4.63, 95% CI = 1.67–12.88) was associated with higher clinical trial enrollment odds, while among White patients, both cervical (OR = 2.21, 95% CI = 1.48–3.29) and ovarian (OR = 3.40, 95% CI = 2.58–4.47) cancer diagnoses (vs. uterine cancer) were associated with higher enrollment odds. Most predictors were associated with clinical trial enrollment odds among White but not Black patients.

Conclusion

Few differences in first-line clinical trial enrollment predictors exist between Black and White gynecologic cancer patients. Although small numbers of Black patients and low clinical trial prevalence are limitations, this descriptive analysis is important in understanding racially disparate clinical trial enrollment.
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Literature
1.
go back to reference Unger JM, LeBlanc M, George S et al (2023) Population, clinical, and scientific impact of national cancer institute’s national clinical trials network treatment studies. J Clin Oncol 41:2020–2028CrossRefPubMed Unger JM, LeBlanc M, George S et al (2023) Population, clinical, and scientific impact of national cancer institute’s national clinical trials network treatment studies. J Clin Oncol 41:2020–2028CrossRefPubMed
2.
go back to reference Adams DV, Long S, Fleury ME (2022) Association of remote technology use and other decentralization tools with patient likelihood to enroll in cancer clinical trials. JAMA Netw Open 5:e2220053CrossRefPubMedPubMedCentral Adams DV, Long S, Fleury ME (2022) Association of remote technology use and other decentralization tools with patient likelihood to enroll in cancer clinical trials. JAMA Netw Open 5:e2220053CrossRefPubMedPubMedCentral
3.
go back to reference Unger JM, Shulman LN, Facktor MA, et al. (2024) National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data. J Clin Oncol. JCO2301030. Unger JM, Shulman LN, Facktor MA, et al. (2024) National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data. J Clin Oncol. JCO2301030.
4.
go back to reference Unger JM, Cook E, Tai E et al (2016) The role of clinical trial participation in cancer research: barriers, evidence, and strategies. American Society of clinical oncology educational book. American Society of clinical oncology. Annual Meeting 35:185–198 Unger JM, Cook E, Tai E et al (2016) The role of clinical trial participation in cancer research: barriers, evidence, and strategies. American Society of clinical oncology educational book. American Society of clinical oncology. Annual Meeting 35:185–198
5.
go back to reference Grant SR, Lin TA, Miller AB, et al. (2020) Racial and Ethnic Disparities Among Participants in US-Based Phase 3 Randomized Cancer Clinical Trials. JNCI cancer spectrum. 4: pkaa060. Grant SR, Lin TA, Miller AB, et al. (2020) Racial and Ethnic Disparities Among Participants in US-Based Phase 3 Randomized Cancer Clinical Trials. JNCI cancer spectrum. 4: pkaa060.
6.
go back to reference Dunlop H, Fitzpatrick E, Kurti K et al (2022) Participation of patients from racial and ethnic minority groups in phase 1 early cancer drug development trials in the US, 2000–2018. JAMA Netw Open 5:e2239884CrossRefPubMedPubMedCentral Dunlop H, Fitzpatrick E, Kurti K et al (2022) Participation of patients from racial and ethnic minority groups in phase 1 early cancer drug development trials in the US, 2000–2018. JAMA Netw Open 5:e2239884CrossRefPubMedPubMedCentral
8.
go back to reference Mishkin G, Minasian LM, Kohn EC et al (2016) The generalizability of NCI-sponsored clinical trials accrual among women with gynecologic malignancies. Gynecol Oncol 143:611–616CrossRefPubMed Mishkin G, Minasian LM, Kohn EC et al (2016) The generalizability of NCI-sponsored clinical trials accrual among women with gynecologic malignancies. Gynecol Oncol 143:611–616CrossRefPubMed
9.
go back to reference Awad E, Paladugu R, Jones N et al (2020) Minority participation in phase 1 gynecologic oncology clinical trials: three decades of inequity. Gynecol Oncol 157:729–732CrossRefPubMed Awad E, Paladugu R, Jones N et al (2020) Minority participation in phase 1 gynecologic oncology clinical trials: three decades of inequity. Gynecol Oncol 157:729–732CrossRefPubMed
10.
go back to reference Grette KV, White AL, Awad EK et al (2021) Not immune to inequity: minority under-representation in immunotherapy trials for breast and gynecologic cancers. Int J Gynecol Cancer 31:1403–1407CrossRefPubMed Grette KV, White AL, Awad EK et al (2021) Not immune to inequity: minority under-representation in immunotherapy trials for breast and gynecologic cancers. Int J Gynecol Cancer 31:1403–1407CrossRefPubMed
11.
go back to reference Wagar MK, Mojdehbakhsh RP, Godecker A et al (2022) Racial and ethnic enrollment disparities in clinical trials of poly(ADP-ribose) polymerase inhibitors for gynecologic cancers. Gynecol Oncol 165:49–52CrossRefPubMed Wagar MK, Mojdehbakhsh RP, Godecker A et al (2022) Racial and ethnic enrollment disparities in clinical trials of poly(ADP-ribose) polymerase inhibitors for gynecologic cancers. Gynecol Oncol 165:49–52CrossRefPubMed
12.
go back to reference Mattei LH, Robb L, Banning K et al (2022) Enrollment of individuals from racial and ethnic minority groups in gynecologic cancer precision oncology trials. Obstet Gynecol 140:654–661PubMed Mattei LH, Robb L, Banning K et al (2022) Enrollment of individuals from racial and ethnic minority groups in gynecologic cancer precision oncology trials. Obstet Gynecol 140:654–661PubMed
13.
go back to reference Khadraoui W, Meade CE, Backes FJ et al (2023) Racial and ethnic disparities in clinical trial enrollment among women with gynecologic cancer. JAMA Netw Open 6:e2346494CrossRefPubMedPubMedCentral Khadraoui W, Meade CE, Backes FJ et al (2023) Racial and ethnic disparities in clinical trial enrollment among women with gynecologic cancer. JAMA Netw Open 6:e2346494CrossRefPubMedPubMedCentral
14.
go back to reference Richardson MT, Barry D, Steinberg JR et al (2024) Underrepresentation of racial and ethnic minority groups in gynecologic oncology: an analysis of over 250 trials. Gynecol Oncol 181:1–7CrossRefPubMed Richardson MT, Barry D, Steinberg JR et al (2024) Underrepresentation of racial and ethnic minority groups in gynecologic oncology: an analysis of over 250 trials. Gynecol Oncol 181:1–7CrossRefPubMed
15.
go back to reference Jorge S, Masshoor S, Gray HJ et al (2023) Participation of patients with limited english proficiency in gynecologic oncology clinical trials. Journal of the National Comprehensive Cancer Network : JNCCN 21:27-32.e2CrossRefPubMed Jorge S, Masshoor S, Gray HJ et al (2023) Participation of patients with limited english proficiency in gynecologic oncology clinical trials. Journal of the National Comprehensive Cancer Network : JNCCN 21:27-32.e2CrossRefPubMed
16.
go back to reference Merkow RP, Rademaker AW, Bilimoria KY (2018) Practical guide to surgical data sets: national cancer database (NCDB). JAMA Surg 153:850–851CrossRefPubMed Merkow RP, Rademaker AW, Bilimoria KY (2018) Practical guide to surgical data sets: national cancer database (NCDB). JAMA Surg 153:850–851CrossRefPubMed
17.
go back to reference Bilimoria KY, Stewart AK, Winchester DP et al (2008) The National Cancer Data Base: a powerful initiative to improve cancer care in the United States. Ann Surg Oncol 15:683–690CrossRefPubMedPubMedCentral Bilimoria KY, Stewart AK, Winchester DP et al (2008) The National Cancer Data Base: a powerful initiative to improve cancer care in the United States. Ann Surg Oncol 15:683–690CrossRefPubMedPubMedCentral
18.
go back to reference von Elm E, Altman DG, Egger M et al (2007) The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Epidemiology 18:800–804CrossRef von Elm E, Altman DG, Egger M et al (2007) The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Epidemiology 18:800–804CrossRef
19.
go back to reference Elshami M, Hue JJ, Hoehn RS et al (2022) A nationwide analysis of clinical trial participation for common hepato-pancreato-biliary malignancies demonstrates survival advantages for subsets of trial patients but disparities in and infrequency of enrollment. HPB (Oxford) 24:1280–1290CrossRefPubMed Elshami M, Hue JJ, Hoehn RS et al (2022) A nationwide analysis of clinical trial participation for common hepato-pancreato-biliary malignancies demonstrates survival advantages for subsets of trial patients but disparities in and infrequency of enrollment. HPB (Oxford) 24:1280–1290CrossRefPubMed
20.
go back to reference White IR, Royston P, Wood AM (2011) Multiple imputation using chained equations: Issues and guidance for practice. Stat Med 30:377–399CrossRefPubMed White IR, Royston P, Wood AM (2011) Multiple imputation using chained equations: Issues and guidance for practice. Stat Med 30:377–399CrossRefPubMed
21.
go back to reference van Buuren S, Groothuis-Oudshoorn K (2011) mice: multivariate imputation by chained equations in R. J Stat Softw 45:1–67CrossRef van Buuren S, Groothuis-Oudshoorn K (2011) mice: multivariate imputation by chained equations in R. J Stat Softw 45:1–67CrossRef
22.
go back to reference Little RJA, Rubin DB. (2020) Statistical Analysis with Missing Data. 3rd ed: John Wiley & Sons, Inc. Little RJA, Rubin DB. (2020) Statistical Analysis with Missing Data. 3rd ed: John Wiley & Sons, Inc.
23.
go back to reference Molenberghs G, Kenward MG. (2007) Multiple Imputation. Missing Data in Clinical Studies. pp. 105–17. Molenberghs G, Kenward MG. (2007) Multiple Imputation. Missing Data in Clinical Studies. pp. 105–17.
24.
go back to reference Robitzsch A, Grund S. (2024) miceadds: Some Additional Multiple Imputation Functions, Especially for ‘mice’. R package version 3.17–44. Robitzsch A, Grund S. (2024) miceadds: Some Additional Multiple Imputation Functions, Especially for ‘mice’. R package version 3.17–44.
25.
go back to reference Unger JM, Vaidya R, Hershman DL et al (2019) Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst 111:245–255CrossRefPubMedPubMedCentral Unger JM, Vaidya R, Hershman DL et al (2019) Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst 111:245–255CrossRefPubMedPubMedCentral
26.
go back to reference Kim ES, Bruinooge SS, Roberts S et al (2017) Broadening eligibility criteria to make clinical trials more representative: American Society of clinical oncology and friends of cancer research joint research statement. J Clin Oncol 35:3737–3744CrossRefPubMedPubMedCentral Kim ES, Bruinooge SS, Roberts S et al (2017) Broadening eligibility criteria to make clinical trials more representative: American Society of clinical oncology and friends of cancer research joint research statement. J Clin Oncol 35:3737–3744CrossRefPubMedPubMedCentral
27.
go back to reference Unger JM, Hershman DL, Till C et al (2021) “When offered to participate”: a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J Natl Cancer Inst 113:244–257CrossRefPubMed Unger JM, Hershman DL, Till C et al (2021) “When offered to participate”: a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. J Natl Cancer Inst 113:244–257CrossRefPubMed
Metadata
Title
Determinants of first-line clinical trial enrollment among Black and White gynecologic cancer patients
Authors
Autumn B. Carey
Caitlin E. Meade
Britton Trabert
Casey M. Cosgrove
Ashley S. Felix
Publication date
03-02-2025
Publisher
Springer International Publishing
Published in
Cancer Causes & Control
Print ISSN: 0957-5243
Electronic ISSN: 1573-7225
DOI
https://doi.org/10.1007/s10552-025-01963-y

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