Esophageal CancerNCT06476067
Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Cancer and Recurrence, run by City of Hope Medical Center at 2 sites in Japan.
Trial summary
The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Cancer, Recurrence, DNA Methylation
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesJapan
- Study dates
- 1 Jan 2006to 18 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- Adult, Older adult
Study population: Patients who had undergone complete esophagectomy.
Who may be able to join
- Patients who had histologically confirmed ESCC.
- Patients who had undergone only complete esophagectomy with radical lymph node dissection without chemotherapy or radiotherapy before or after surgery.
- Patients for whom tissue samples are available
- Patients who were followed-up completely, with information on observation periods of at least 2 years after surgery.
- Written informed consent following full study information is provided to the patient.
Who cannot join
- Patients lacking clinical information within 2 years of surgery.
- Patients with multiple cancers.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites, 2 recruiting
- Recruiting
Yamanashi Universiy
Chūō, Yamanashi, 4093898
Katsutoshi Shoda, PhD, kshoda@yamanashi.ac.jp
- Recruiting
Nagoya University
Nagoya, Aichi-ken, 4668560
Fuminori Sonohara, PhD, Fuminori.sonohara@bswhealth.org
About this study
Official title: Predicting Postoperative Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Epigenomic alterations such as DNA methylation have attracted attention as promising biomarkers. The investigators aim to predict early recurrence based on whole genome DNA methylation analysis of esophageal cancer.
Read the detailed description
Prognosis for patients with esophageal squamous cell carcinoma (ESCC) remains poor. Surgery is one of the standard treatments for patients with ESCC who are considered to have a curative resection, however, approximately 40% of patients develop tumor recurrence within two years after surgery. The main cause of poor prognosis in ESCC patients undergoing surgery is postoperative tumor recurrence due to the presence of latent micro-metastases at the time of surgery. Even with today's advances in preoperative diagnostic techniques, predicting early tumor recurrence remains difficult due to the lack of established methods. Epigenetic markers, especially DNA methylation, are considered ideal markers for predicting cancer metastasis due to their cancer-specific methylation patterns, biological stability, and technical reproducibility. Our study aims to evaluate methylation of surgical specimens to assess residual disease and predict early recurrence.
- Conditions
- Esophageal Cancer, Recurrence, DNA Methylation
- Being tested
- Surgery
- Medical subject headings
- Esophageal Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Esophagectomy
| Study group | Role | What they receive |
|---|---|---|
| Patients with postoperative early tumor recurrence with ESCC （Training) | Patients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) Receives: Procedure: Surgery | |
| Patients without postoperative early tumor recurrence with ESCC （Training) | Patients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) Receives: Procedure: Surgery | |
| Patients with postoperative early tumor recurrence with ESCC （Validation) | Patients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) Receives: Procedure: Surgery | |
| Patients without postoperative early tumor recurrence with ESCC （Validation) | Patients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival（RFS)
Time from curative-intent resection to the development of recurrence (or death)
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jan 2006
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koichi Takiguchi, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476067
- Sponsor's protocol ID
- 23228/ESCC-Erec
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brown LM, Devesa SS, Chow WH. Incidence of adenocarcinoma of the esophagus among white Americans by sex, stage, and age. J Natl Cancer Inst. 2008 Aug 20;100(16):1184-7. doi: 10.1093/jnci/djn211. Epub 2008 Aug 11.
PubMed 18695138Sawada G, Niida A, Uchi R, Hirata H, Shimamura T, Suzuki Y, Shiraishi Y, Chiba K, Imoto S, Takahashi Y, Iwaya T, Sudo T, Hayashi T, Takai H, Kawasaki Y, Matsukawa T, Eguchi H, Sugimachi K, Tanaka F, Suzuki H, Yamamoto K, Ishii H, Shimizu M, Yamazaki H, Yamazaki M, Tachimori Y, Kajiyama Y, Natsugoe S, Fujita H, Mafune K, Tanaka Y, Kelsell DP, Scott CA, Tsuji S, Yachida S, Shibata T, Sugano S, Doki Y, Akiyama T, Aburatani H, Ogawa S, Miyano S, Mori M, Mimori K. Genomic Landscape of Esophageal Squamous Cell Carcinoma in a Japanese Population. Gastroenterology. 2016 May;150(5):1171-1182. doi: 10.1053/j.gastro.2016.01.035. Epub 2016 Feb 10.
PubMed 26873401Cui Y, Chen H, Xi R, Cui H, Zhao Y, Xu E, Yan T, Lu X, Huang F, Kong P, Li Y, Zhu X, Wang J, Zhu W, Wang J, Ma Y, Zhou Y, Guo S, Zhang L, Liu Y, Wang B, Xi Y, Sun R, Yu X, Zhai Y, Wang F, Yang J, Yang B, Cheng C, Liu J, Song B, Li H, Wang Y, Zhang Y, Cheng X, Zhan Q, Li Y, Liu Z. Whole-genome sequencing of 508 patients identifies key molecular features associated with poor prognosis in esophageal squamous cell carcinoma. Cell Res. 2020 Oct;30(10):902-913. doi: 10.1038/s41422-020-0333-6. Epub 2020 May 12.
PubMed 32398863Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J. Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial. JAMA Surg. 2021 Aug 1;156(8):721-729. doi: 10.1001/jamasurg.2021.2373.
PubMed 34160577Leng X, He W, Yang H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Liu H, Yang H, Li T, Zhang X, Li Q, Wang G, Mao T, Guo X, Lin T, Liu M, Fu J, Han Y. Prognostic Impact of Postoperative Lymph Node Metastases After Neoadjuvant Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus: From the Results of NEOCRTEC5010, a Randomized Multicenter Study. Ann Surg. 2021 Dec 1;274(6):e1022-e1029. doi: 10.1097/SLA.0000000000003727.
PubMed 31855875Guo H, Zhu H, Xi Y, Zhang B, Li L, Huang Y, Zhang J, Fu Z, Yang G, Yuan S, Yu J. Diagnostic and prognostic value of 18F-FDG PET/CT for patients with suspected recurrence from squamous cell carcinoma of the esophagus. J Nucl Med. 2007 Aug;48(8):1251-8. doi: 10.2967/jnumed.106.036509. Epub 2007 Jul 13.
PubMed 17631554Shuto K, Kono T, Shiratori T, Akutsu Y, Uesato M, Mori M, Narushima K, Imanishi S, Nabeya Y, Yanagawa N, Okazumi S, Koda K, Matsubara H. Diagnostic performance of diffusion-weighted magnetic resonance imaging in assessing lymph node metastasis of esophageal cancer compared with PET. Esophagus. 2020 Jul;17(3):239-249. doi: 10.1007/s10388-019-00704-w. Epub 2019 Dec 9.
PubMed 31820208Ajani JA, D'Amico TA, Bentrem DJ, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Farjah F, Gerdes H, Gibson M, Grierson P, Hofstetter WL, Ilson DH, Jalal S, Keswani RN, Kim S, Kleinberg LR, Klempner S, Lacy J, Licciardi F, Ly QP, Matkowskyj KA, McNamara M, Miller A, Mukherjee S, Mulcahy MF, Outlaw D, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian NR, Pluchino LA. Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023 Apr;21(4):393-422. doi: 10.6004/jnccn.2023.0019.
PubMed 37015332Semenkovich TR, Hudson JL, Subramanian M, Mullady DK, Meyers BF, Puri V, Kozower BD. Trends in Treatment of T1N0 Esophageal Cancer. Ann Surg. 2019 Sep;270(3):434-443. doi: 10.1097/SLA.0000000000003466.
PubMed 31274653Tang C, Livingston MJ, Safirstein R, Dong Z. Cisplatin nephrotoxicity: new insights and therapeutic implications. Nat Rev Nephrol. 2023 Jan;19(1):53-72. doi: 10.1038/s41581-022-00631-7. Epub 2022 Oct 13.
PubMed 36229672Perazella MA, Moeckel GW. Nephrotoxicity from chemotherapeutic agents: clinical manifestations, pathobiology, and prevention/therapy. Semin Nephrol. 2010 Nov;30(6):570-81. doi: 10.1016/j.semnephrol.2010.09.005.
PubMed 21146122Liu Z, Zhao Y, Kong P, Liu Y, Huang J, Xu E, Wei W, Li G, Cheng X, Xue L, Li Y, Chen H, Wei S, Sun R, Cui H, Meng Y, Liu M, Li Y, Feng R, Yu X, Zhu R, Wu Y, Li L, Yang B, Ma Y, Wang J, Zhu W, Deng D, Xi Y, Wang F, Li H, Guo S, Zhuang X, Wang X, Jiao Y, Cui Y, Zhan Q. Integrated multi-omics profiling yields a clinically relevant molecular classification for esophageal squamous cell carcinoma. Cancer Cell. 2023 Jan 9;41(1):181-195.e9. doi: 10.1016/j.ccell.2022.12.004. Epub 2022 Dec 29.
PubMed 36584672Azad TD, Chaudhuri AA, Fang P, Qiao Y, Esfahani MS, Chabon JJ, Hamilton EG, Yang YD, Lovejoy A, Newman AM, Kurtz DM, Jin M, Schroers-Martin J, Stehr H, Liu CL, Hui AB, Patel V, Maru D, Lin SH, Alizadeh AA, Diehn M. Circulating Tumor DNA Analysis for Detection of Minimal Residual Disease After Chemoradiotherapy for Localized Esophageal Cancer. Gastroenterology. 2020 Feb;158(3):494-505.e6. doi: 10.1053/j.gastro.2019.10.039. Epub 2019 Nov 9.
PubMed 31711920Kandimalla R, Xu J, Link A, Matsuyama T, Yamamura K, Parker MI, Uetake H, Balaguer F, Borazanci E, Tsai S, Evans D, Meltzer SJ, Baba H, Brand R, Von Hoff D, Li W, Goel A. EpiPanGI Dx: A Cell-free DNA Methylation Fingerprint for the Early Detection of Gastrointestinal Cancers. Clin Cancer Res. 2021 Nov 15;27(22):6135-6144. doi: 10.1158/1078-0432.CCR-21-1982. Epub 2021 Aug 31.
PubMed 34465601Roy R, Kandimalla R, Sonohara F, Koike M, Kodera Y, Takahashi N, Yamada Y, Goel A. A comprehensive methylation signature identifies lymph node metastasis in esophageal squamous cell carcinoma. Int J Cancer. 2019 Mar 1;144(5):1160-1169. doi: 10.1002/ijc.31755. Epub 2018 Oct 16.
PubMed 30006931
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Postoperative Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06476067
- Acronym / sponsor ID
- 23228/ESCC-Erec
- Conditions
- Esophageal Cancer, Recurrence, DNA Methylation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 26 Jun 2024 (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.
The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Epigenomic alterations such as DNA methylation have attracted attention as promising biomarkers. The investigators aim to predict early recurrence based on whole genome DNA methylation analysis of esophageal cancer.
Detailed description
Prognosis for patients with esophageal squamous cell carcinoma (ESCC) remains poor. Surgery is one of the standard treatments for patients with ESCC who are considered to have a curative resection, however, approximately 40% of patients develop tumor recurrence within two years after surgery. The main cause of poor prognosis in ESCC patients undergoing surgery is postoperative tumor recurrence due to the presence of latent micro-metastases at the time of surgery. Even with today's advances in preoperative diagnostic techniques, predicting early tumor recurrence remains difficult due to the lack of established methods. Epigenetic markers, especially DNA methylation, are considered ideal markers for predicting cancer metastasis due to their cancer-specific methylation patterns, biological stability, and technical reproducibility. Our study aims to evaluate methylation of surgical specimens to assess residual disease and predict early recurrence.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with postoperative early tumor recurrence with ESCC （Training) | – | Procedure: SurgeryPatients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) |
| Patients without postoperative early tumor recurrence with ESCC （Training) | – | Procedure: SurgeryPatients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) |
| Patients with postoperative early tumor recurrence with ESCC （Validation) | – | Procedure: SurgeryPatients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) |
| Patients without postoperative early tumor recurrence with ESCC （Validation) | – | Procedure: SurgeryPatients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who had undergone complete esophagectomy.
Key inclusion criteria (5 listed)
- Patients who had histologically confirmed ESCC.
- Patients who had undergone only complete esophagectomy with radical lymph node dissection without chemotherapy or radiotherapy before or after surgery.
- Patients for whom tissue samples are available
- Patients who were followed-up completely, with information on observation periods of at least 2 years after surgery.
- Written informed consent following full study information is provided to the patient.
Key exclusion criteria (2 listed)
- Patients lacking clinical information within 2 years of surgery.
- Patients with multiple cancers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryEsophagectomy | Procedure or surgery | Patients with postoperative early tumor recurrence with ESCC （Training), Patients with postoperative early tumor recurrence with ESCC （Validation), Patients without postoperative early tumor recurrence with ESCC （Training), Patients without postoperative early tumor recurrence with ESCC （Validation) |
Primary outcome
Recurrence-free Survival（RFS)
Time frame: Up to 60 months
Time from curative-intent resection to the development of recurrence (or death)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 18695138Brown LM, Devesa SS, Chow WH. Incidence of adenocarcinoma of the esophagus among white Americans by sex, stage, and age. J Natl Cancer Inst. 2008 Aug 20;100(16):1184-7. doi: 10.1093/jnci/djn211. Epub 2008 Aug 11.
- Background: PubMed 26873401Sawada G, Niida A, Uchi R, Hirata H, Shimamura T, Suzuki Y, Shiraishi Y, Chiba K, Imoto S, Takahashi Y, Iwaya T, Sudo T, Hayashi T, Takai H, Kawasaki Y, Matsukawa T, Eguchi H, Sugimachi K, Tanaka F, Suzuki H, Yamamoto K, Ishii H, Shimizu M, Yamazaki H, Yamazaki M, Tachimori Y, Kajiyama Y, Natsugoe S, Fujita H, Mafune K, Tanaka Y, Kelsell DP, Scott CA, Tsuji S, Yachida S, Shibata T, Sugano S, Doki Y, Akiyama T, Aburatani H, Ogawa S, Miyano S, Mori M, Mimori K. Genomic Landscape of Esophageal Squamous Cell Carcinoma in a Japanese Population. Gastroenterology. 2016 May;150(5):1171-1182. doi: 10.1053/j.gastro.2016.01.035. Epub 2016 Feb 10.
- Background: PubMed 32398863Cui Y, Chen H, Xi R, Cui H, Zhao Y, Xu E, Yan T, Lu X, Huang F, Kong P, Li Y, Zhu X, Wang J, Zhu W, Wang J, Ma Y, Zhou Y, Guo S, Zhang L, Liu Y, Wang B, Xi Y, Sun R, Yu X, Zhai Y, Wang F, Yang J, Yang B, Cheng C, Liu J, Song B, Li H, Wang Y, Zhang Y, Cheng X, Zhan Q, Li Y, Liu Z. Whole-genome sequencing of 508 patients identifies key molecular features associated with poor prognosis in esophageal squamous cell carcinoma. Cell Res. 2020 Oct;30(10):902-913. doi: 10.1038/s41422-020-0333-6. Epub 2020 May 12.
- Background: PubMed 34160577Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J. Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial. JAMA Surg. 2021 Aug 1;156(8):721-729. doi: 10.1001/jamasurg.2021.2373.
- Background: PubMed 31855875Leng X, He W, Yang H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Liu H, Yang H, Li T, Zhang X, Li Q, Wang G, Mao T, Guo X, Lin T, Liu M, Fu J, Han Y. Prognostic Impact of Postoperative Lymph Node Metastases After Neoadjuvant Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus: From the Results of NEOCRTEC5010, a Randomized Multicenter Study. Ann Surg. 2021 Dec 1;274(6):e1022-e1029. doi: 10.1097/SLA.0000000000003727.
- Background: PubMed 17631554Guo H, Zhu H, Xi Y, Zhang B, Li L, Huang Y, Zhang J, Fu Z, Yang G, Yuan S, Yu J. Diagnostic and prognostic value of 18F-FDG PET/CT for patients with suspected recurrence from squamous cell carcinoma of the esophagus. J Nucl Med. 2007 Aug;48(8):1251-8. doi: 10.2967/jnumed.106.036509. Epub 2007 Jul 13.
- Background: PubMed 31820208Shuto K, Kono T, Shiratori T, Akutsu Y, Uesato M, Mori M, Narushima K, Imanishi S, Nabeya Y, Yanagawa N, Okazumi S, Koda K, Matsubara H. Diagnostic performance of diffusion-weighted magnetic resonance imaging in assessing lymph node metastasis of esophageal cancer compared with PET. Esophagus. 2020 Jul;17(3):239-249. doi: 10.1007/s10388-019-00704-w. Epub 2019 Dec 9.
- Background: PubMed 37015332Ajani JA, D'Amico TA, Bentrem DJ, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Farjah F, Gerdes H, Gibson M, Grierson P, Hofstetter WL, Ilson DH, Jalal S, Keswani RN, Kim S, Kleinberg LR, Klempner S, Lacy J, Licciardi F, Ly QP, Matkowskyj KA, McNamara M, Miller A, Mukherjee S, Mulcahy MF, Outlaw D, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian NR, Pluchino LA. Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023 Apr;21(4):393-422. doi: 10.6004/jnccn.2023.0019.
- Background: PubMed 31274653Semenkovich TR, Hudson JL, Subramanian M, Mullady DK, Meyers BF, Puri V, Kozower BD. Trends in Treatment of T1N0 Esophageal Cancer. Ann Surg. 2019 Sep;270(3):434-443. doi: 10.1097/SLA.0000000000003466.
- Background: PubMed 36229672Tang C, Livingston MJ, Safirstein R, Dong Z. Cisplatin nephrotoxicity: new insights and therapeutic implications. Nat Rev Nephrol. 2023 Jan;19(1):53-72. doi: 10.1038/s41581-022-00631-7. Epub 2022 Oct 13.
- Background: PubMed 21146122Perazella MA, Moeckel GW. Nephrotoxicity from chemotherapeutic agents: clinical manifestations, pathobiology, and prevention/therapy. Semin Nephrol. 2010 Nov;30(6):570-81. doi: 10.1016/j.semnephrol.2010.09.005.
- Background: PubMed 36584672Liu Z, Zhao Y, Kong P, Liu Y, Huang J, Xu E, Wei W, Li G, Cheng X, Xue L, Li Y, Chen H, Wei S, Sun R, Cui H, Meng Y, Liu M, Li Y, Feng R, Yu X, Zhu R, Wu Y, Li L, Yang B, Ma Y, Wang J, Zhu W, Deng D, Xi Y, Wang F, Li H, Guo S, Zhuang X, Wang X, Jiao Y, Cui Y, Zhan Q. Integrated multi-omics profiling yields a clinically relevant molecular classification for esophageal squamous cell carcinoma. Cancer Cell. 2023 Jan 9;41(1):181-195.e9. doi: 10.1016/j.ccell.2022.12.004. Epub 2022 Dec 29.
- Individual participant dataSharing planned: Undecided
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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.
Koichi Takiguchi, PhD principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Recurrence, run by City of Hope Medical Center at 2 sites in Japan.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ajay Goel, PhD (6262183452, AJGOEL@COH.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival（RFS) (time frame: Up to 60 months). 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 NCT06476067, which also lists 24 linked publications.
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 Jul 2026.