Clinical trial NCT05177393: Treatment Outcomes of Esophageal Cancer
Official title: Treatment Outcomes of Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Keywords: Treatment outcomes
Quality of life
Comparative effectiveness
Palliation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Westat
name: African Esophageal Cancer Consortium (AfrECC)
name: National Cancer Institute (NCI)
name: Celgene Corporation
First posted: 2022-01-04
Enrollment: 2476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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 biopsy.
* Age 18 years of age or older;

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Proportion of esophageal cancer (EC) participants receiving treatment with varying treatment modalities at participating AfrECC sites
timeFrame: Up to 4 years
measure: Change in scores of the Modified Rosenblatt Index over time
timeFrame: Up to 4 years
measure: Median Overall Survival
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bomet
country: Kenya
facility: Tenwek Hospital
city: Eldoret
country: Kenya
facility: Moi Teaching and Referral Hospital
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hospital
city: Dar es Salaam
country: Tanzania
facility: Muhimbili National Hospital
city: Dar es Salaam
country: Tanzania
facility: Ocean Road Cancer Institute
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
Study officials:
affiliation: University of California, San Francisco
name: Geoffrey Buckle, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Katherine Van Loon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.