Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05764044 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer

Study acronym: AddChemo
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 9 more changesShow less
    • Enrollment target: 50 to 365
    • Primary completion date: Oct 30, 2023 to Dec 31, 2026
    • Start date changed from estimate of Apr 1, 2023 to Mar 27, 2024
    • Primary endpoints: 6 to 1
    • Study sites: 1 to 26
    • Study completion date: Dec 30, 2023 to Dec 31, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 5 to 4
    • Study description expanded, about 21 words
  2. Start date: Mar 1, 2023 to Apr 1, 2023v2 Show 4 more changesShow less
    • Secondary endpoints: details revised at 2 of 5 entries
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 2 words
    • Study title shortened, about 2 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study hypothesizes that patients who persist with cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) plasma expression at the end of standard treatment, can derive the benefit of using adjuvant chemotherapy in locally advanced cervical cancer (CC). After standard treatment based on concomitant chemoradiotherapy regime, a qualitative and quantitative research of cfHPV-DNA in plasma of patients will be conducted. Patients who have positive research for plasma cfHPV-DNA at the end of chemoradiotherapy treatment will be randomized to receive two additional cycles of adjuvant chemotherapy or observation. Patients will be followed with conduction of computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months.
Trial Details
NCT Number NCT05764044
Lead Sponsor Hospital do Coracao
Collaborators: University of Sao Paulo
Conditions
(from sponsor)		 Cervical Cancer, Cervix Cancer, Cervix Neoplasm
Related terms Uterine Cervical Neoplasms
Enrollment 365 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov