ClinicalTrials.gg
RecruitingNCT05177393Updated Jul 22, 2026

Treatment Outcomes of Esophageal Cancer

An observational study in Esophageal Cancer, sponsored by University of California, San Francisco. Recruiting at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by University of California, San Francisco · Observational

From the registry’s dates

  • Started Feb 2019; still recruiting 7 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,476
Ages
18 Years and older
Sex
All
01

Study summary

This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.

Read the detailed description

SPECIFIC AIMS:

Aim 1: To describe the types of treatments administered for all patients diagnosed with EC at participating AfrECC sites, including chemotherapeutic regimens, radiation therapy, chemo-radiotherapy, esophageal stenting, esophagectomy, and basic supportive care.

Aim 2: To evaluate the effect of different EC treatment modalities on patient reported outcomes during and after completion of treatment.

Aim 3: To measure the effect of different treatment modalities on overall survival.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Treatment outcomes
  • Quality of life
  • Comparative effectiveness
  • Palliation
03

In context

Esophageal Neoplasms

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

This study's planned enrollment of 2,476 is above the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Participants with esophageal cancer based on histological confirmation or presumptive clinical diagnosis who reside in Kenya, Tanzania, and Malawi.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants with histopathologically confirmed or presumptive clinical diagnosis of EC. For patients who do not have histopathologically confirmed disease, presumptive clinical diagnosis may be based upon barium swallow or endoscopy without .
  • Age 18 years of age or older;

Exclusion criteria

Exclusion Criteria:

  • Unable to provide
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,476 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants with Esophageal Cancer

    Participants with esophageal cancer will be administered questionnaires, and medical charts will be accessed to collect study related data.

    Other: Assessment of patient-reported outcomes (PROs)

Interventions

  • OtherAssessment of patient-reported outcomes (PROs)

    Questionnaires will be administered to participants

    Also known as: PROs

06

What researchers measure

Primary outcomes

  1. Proportion of esophageal cancer (EC) participants receiving treatment with varying treatment modalities at participating AfrECC sites

    Descriptive statistics will be used to describe the proportion of EC patients receiving treatment with each modality at participating AfrECC sites. The investigators will assess the associations between demographic and clinicopathologic characteristic and treatment modalities employed (chemotherapy, radiotherapy, chemo-radiation, esophageal stenting, esophagectomy, supportive care alone, or a combination of these treatments)

    Time frame: Up to 4 years

  2. Change in scores of the Modified Rosenblatt Index over time

    The 6-item Modified Rosenblatt Index by Rosenblatt, et al. adapted for use within a resource-limited context evaluates EC related parameters scored on a Likert scale assessing presence and severity of symptoms: Odynophagia (0=no pain on swallowing to 3=severe pain); Dysphagia (0=normal, no dysphagia to 4=unable to swallow saliva); Regurgitation (0=never to 3=constant); Chest and/or Back Pain (0=no pain to 2=pain not relieved by non-narcotics or requiring opiate medication); World Health Organization (WHO) performance status/Overall Well-Being (0="A lot better" to 4="A lot worse"). Scores will be assessed at the following time points: Baseline, 1 month and 3 months after initiation of treatment, and every 3 months thereafter.

    Time frame: Up to 4 years

  3. Median Overall Survival

    Survival will be defined as the time elapsed from date of diagnosis (either confirmed or date of diagnostic modality leading to presumptive clinical diagnosis) to date of death. For participants who are not deceased, censorship will be performed on the date when the participant was last known to be alive.

    Time frame: Up to 4 years

07

Study locations

6 of 6 sites recruiting
  • Tenwek Hospital
    Bomet, Kenya
    Recruiting
    • Michael Mwachiro, MBChB · Principal investigator
  • Moi Teaching and Referral Hospital
    Eldoret, Kenya
    Recruiting
    • Fatma F Some, MBChB, MMed · Principal investigator
  • Kamuzu Central Hospital
    Lilongwe, Malawi
    Recruiting
    • Gift Mulima, MBBS · Principal investigator
  • Muhimbili National Hospital
    Dar es Salaam, Tanzania
    Recruiting
    • Yona Ringo, MD, MMed · Principal investigator
  • Ocean Road Cancer Institute
    Dar es Salaam, Tanzania
    Recruiting
    • Alita Mrema, MD, MMed · Principal investigator
  • Kilimanjaro Christian Medical Centre
    Moshi, Tanzania
    Recruiting
    • Blandina Mmbaga, MD, MMed,PhD · Principal investigator
08

References and documents

Publications

  • Mulima G, Mody GN, Kaimila B, Salima A, Williams B, Paciorek A, Zhang L, Charles A, Westmoreland KD, Van Loon K, Buckle GC. Treatment Outcomes of Esophageal Cancer in Malawi: An Analysis of Overall Survival and Patient-Reported Outcomes. JCO Glob Oncol. 2025 Nov;11:e2500221. doi: 10.1200/GO-25-00221. Epub 2025 Nov 13. PubMed 41232057 ↗
  • Buckle GC, Mrema A, Mwachiro M, Ringo Y, Selekwa M, Mulima G, Some FF, Mmbaga BT, Mody GN, Zhang L, Paciorek A, Akoko L, Ayuo P, Burgert S, Bukusi E, Charles A, Chepkemoi W, Chesumbai G, Kaimila B, Kenseko A, Kibwana KS, Koech D, Macharia C, Moirana EN, Mushi BP, Mremi A, Mwaiselage J, Mwanga A, Ndumbalo J, Nvakunga G, Ngoma M, Oduor M, Oloo M, Opakas J, Parker R, Seno S, Salima A, Servent F, Wandera A, Westmoreland KD, White RE, Williams B, Mmbaga EJ, Van Loon K; of the African Esophageal Cancer Consortium (AfrECC). Treatment outcomes of esophageal cancer in Eastern Africa: protocol of a multi-center, prospective, observational, open cohort study. BMC Cancer. 2022 Jan 19;22(1):82. doi: 10.1186/s12885-021-09124-5. PubMed 35045815 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05177393
Collaborators
Westat, African Esophageal Cancer Consortium (AfrECC), Celgene Corporation
Responsible party
Sponsor
First posted
Jan 4, 2022
Start date
Feb 28, 2019
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 22, 2026

Study contacts

Geoffrey Buckle, MD, MPH
Contact
geoffrey.buckle@ucsf.edu
(415) 476-1528
Geoffrey Buckle, MD, MPH
principal investigator · University of California, San Francisco
Katherine Van Loon, MD, MPH
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion