Health Trials

Treatment Outcomes of Esophageal Cancer

ConditionEsophageal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Unable to provide informed consent

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Assessment of patient-reported outcomes (PROs)

    Other intervention

    Questionnaires will be administered to participants

Treatment groups

2,476 Participants
are divided into 1 treatment group
Group A: Participants with Esophageal Cancer1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

Westat

Collaborator

African Esophageal Cancer Consortium (AfrECC)

Collaborator

Celgene Corporation

Collaborator

Source ClinicalTrials.gov
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