POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric (POP-UP)

September 14, 2026 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study

This is a prospective, multicenter, two-cohort, open-label, single-arm feasibility study of a trimodal (nutritional, psychological, and personalized Adapted Physical Activity (APA)-individualized interventions) 8-week prehabilitation program in patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) receiving peri-operative triple chemotherapy and undergoing surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The POP-UP study aims to evaluate the feasibility of an 8-week trimodal pre/posthabilitation program (consisting of APA, nutritional assessment, and psychological support) with remote monitoring of the APA sessions and nurse coordination alongside perioperative triplet chemotherapy in patients with localized PDAC (resectable or borderline resectable tumor) or OGC (≥ cT2 or N+).

The prehabilitation program will be conducted during neoadjuvant chemotherapy and the 3-5 weeks prior to surgery for a total of 8 weeks before surgery. There will be a total of three prehabilitation hospital days during the prehabilitation program.

The preoperative prehabilitation will include:

  • Once per month, a prehabilitation hospital-day with functional capacities assessment with validated tests made by a physiotherapist or an APA professional (according of center resources/functioning), medical and nurse assessment evaluating performance status, chemotherapy toxicity and tolerance, and nutritional assessment (according to the functioning of each center it will be made by these professionals -with university training on nutrition- or a dietician). A therapeutic training session on the adherence to the prehabilitation program will be done by the nurse (trained in therapeutic education).
  • Weekly, an APA professional trainer will follow via using app (Activiti®) the APA home-based program. It will be based on the functional capacities assessment made during the prehabilitation hospital day. The exercise training program will consist of twice per week autonomy sessions, supervised and adapted by the APA professional, and once per week a guided session with the APA professional. The patient will have a total of 3 physical activity sessions per week.
  • Once per week, the nurse practitioner (or case manager, according to center functioning) will evaluate the patient via a videoconference to assess the chemotherapy toxicity and tolerance and patient's weight modifications.

The posthabilitation program will start for a total of 8 weeks, one week after surgery discharge. The structure is the same as the prehabilitation program except for the follow of chemotherapy toxicity and tolerance that will be replaced by the follow of the surgical complications/consequences. There will be a total of three posthabilitation days at hospital during the posthabilitation program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Dijon, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire Dijon Bourgogne
        • Contact:
          • Olivier FACY, MD
      • Grenoble, France
        • Not yet recruiting
        • Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
        • Contact:
          • Camille HERVE, MD
      • Lille, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Lille
        • Contact:
          • PIESSEN Guillaume, MD
      • Marseille, France
        • Not yet recruiting
        • Institut Paoli-Calmettes
        • Contact:
          • Brice CHANEZ, MD
      • Marseille, France
        • Not yet recruiting
        • Hospital La Timone
        • Contact:
          • Laetitia DAHAN, MD
      • Reims, France
        • Not yet recruiting
        • CHU de Reims
        • Contact:
          • Olivier BOUCHE, MD
      • Rouen, France
        • Not yet recruiting
        • CENTRE HOSPITALIER UNIVERSITAIRE ROUEN - CHU Charles Nicolle
        • Contact:
          • Lilian SCHWARZ, MD
      • Saint-Cloud, France
        • Recruiting
        • INSTITUT CURIE de SAint Cloud
        • Contact:
          • Cindy NEUZILLET, MD
      • Saint-Herblain, France
        • Not yet recruiting
        • Institut de Cancerologie de L'Ouest Rene Gauducheau
        • Contact:
          • Damien VANSTEENE, MD
      • St-Malo, France
        • Not yet recruiting
        • Groupe hospitalier Rance Emeraude (CHU Saint-Malo)
        • Contact:
          • Anais BODERE, MD
      • Tours, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire Tours - Hopital Trousseau
        • Contact:
          • Thierry LECOMTE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed and dated patient informed consent form (ICF) and willingness to comply with all study procedures and availability for the study duration,
  2. Histologically or cytologically proven, localized PDAC or OGC,
  3. Indication to a neoadjuvant treatment with triplet chemotherapy for ≥ 4 cycles (8 weeks) validated by the multidisciplinary board, Note: Patient treated for PDAC, dose reduction of oxaliplatin or irinotecan is authorized.
  4. Age > 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if < 14 validation of oncogeriatric specialist,
  5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at the inclusion visit,
  6. No prior treatment for PDAC or OGC before starting chemotherapy (FLOT or FOLFIRINOX),
  7. At least one measurable or evaluable lesion as assessed by Computerized Tomography scan or Magnetic resonance imaging according to RECIST 1.1 and feasibility of repeated radiological assessments,
  8. Adequate hematologic and end-organ function allowing the triple combination chemotherapy protocol,
  9. Registration in a national health care system (PUMa - Protection Universelle Maladie included).

Exclusion Criteria:

  1. Evidence of metastatic disease at imaging (validated in multidisciplinary team evaluation),
  2. Histology of other than adenocarcinoma,
  3. Any medical (including cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
  4. Patients with medical contraindication to surgery due to general condition or comorbidities
  5. Pregnancy or breast-feeding,
  6. Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Cohort 1 and Cohort 2

Cohort 1 - Patients with PDAC

Cohort 2 - Patients with OGC
Other: Prehabilitation program

Cohort 1 - Prehabilitation program will be implemented during the last cycles of neoadjuvant chemotherapy (cycle 5 - cycle 6 or cycle 6 - cycle 8) and the weeks preceding surgery (planned 3-4 weeks after the last chemotherapy cycle)

Cohort 2 - Prehabilitation program will be implemented during the last cycles of neoadjuvant chemotherapy (cycle 2 - cycle 4) and the weeks preceding surgery (planned 3-4 weeks after the last chemotherapy cycle)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The feasibility of personalized, 8-week trimodal pre-habilitation program alongside perioperative triplet chemotherapy
Time Frame: 8 weeks

The success of pre-habilitation is defined by the achievement of the following three criteria:

  1. At least 75% of the (minimum) planned APA sessions, 6 of 8 sessions with an APA professional and 12 of 16 sessions in autonomy with remote APA supervision (note: the total number of APA sessions can be adapted according to the physical activity level of the patient, with a minimum of 8 supervised sessions and 16 autonomy sessions) and
  2. Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and
  3. Psychological or psychiatric visit before the surgery in function of practice center /resources if a psychological need is shown by Hospital Anxiety and Depression Scale (HADS).
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Success rate of APA, nutritional, and psychological interventions
Time Frame: 8 weeks
Evaluates completion and adherence of each intervention separately according to predefined success criteria. Unit of Measure: Proportion of patients (%) achieving predefined success criteria
8 weeks
Overall survival (OS) assessment
Time Frame: up to 12 months after surgery
OS defined as time (months) between the date of inclusion and 12 months after surgery
up to 12 months after surgery
Disease-free survival (DFS) assessment
Time Frame: up to 12 months after surgery
DFS defined as the time (months) between the date inclusion and the date corresponding at 12 months after surgery
up to 12 months after surgery
Nurse intervention assessment
Time Frame: 8 weeks
The nurse intervention will be evaluated by: Unit of Measure: Number of alerts managed by nurses and oncologists, Weekly remote follow-up completion rate (%), Scheduled vs. completed prehabilitation/posthabilitation sessions (%), and Hospital days
8 weeks
G-CSF use and neutropenia assessment
Time Frame: 8 weeks
Hematologic support and neutropenia will be evaluated. Unit of Measure: G-CSF prescription (yes/no), rate of grade ≥2 neutropenia (%)
8 weeks
Perioperative chemotherapy rate assessment
Time Frame: 8 weeks
Assessing completion of scheduled perioperative chemotherapy cycles in eligible patients. Unit of Measure: Number/proportion of patients with planned vs received number of perioperative chemotherapy cycles.
8 weeks
Chemotherapy dose received
Time Frame: 8 weeks
Relative dose intensity will be measured. Unit of Measure: Percentage of planned dose received (%)
8 weeks
Health-related quality of life assessment by EORTC QLQ-C30
Time Frame: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
HRQoL will be assessed by using the EORTC QLQ-C30 questionnaire at screening, once per month and at the end of intervention visit. The EORTC QLQ-C30 is a cancer specific questionnaire assessing 15 HRQOL scales through 30-items; for each dimension, one score is generated according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level, a high Global QoL level, and a high symptomatic level.
Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Health-related quality of life assessment by EORTC QLQ-PAN26
Time Frame: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
The EORTC QLQ-PAN26 is a module specific to pancreatic cancer, to be used in conjunction to the EORTC QLQ-C30. It contains 26 items. As for the EORTC QLQ-C30, one score is generated for each score according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level and a high symptomatic level.
Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Health-related quality of life assessment by EORTC QLQ-OG25
Time Frame: Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
The EORTC QLQ-OG25 is a module specific to esophago-gastric cancer to use in conjunction to the EORTC QLQ-C30. It contains 25 items. One score is generated for each score according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level and a high symptomatic level
Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months)
Chemotherapy tolerance assessment
Time Frame: 8 weeks
The chemotherapy tolerance with the CTCAE V5.0 (Grade ≥ 3) will be evaluated. Unit of Measure: Number and proportion of patients with Grade ≥3 toxicities (CTCAE v5.0) Toxicities requiring hospitalization, treatment delays, and dose reductions related to toxicity will also be assessed
8 weeks
Postoperative complications assessment
Time Frame: Surgery and postoperative period (up to 90 days post-surgery)
Major postoperative complications will be measured. Unit of Measure: Number/proportion of patients with Clavien-Dindo Grade ≥3 complications - evaluates serious surgical complications requiring intervention under anesthesia, ICU care, or resulting in death.
Surgery and postoperative period (up to 90 days post-surgery)
Adherence to APA program assessment
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Tracks patient participation in post-habilitation APA sessions and documents reasons for drop-out. Unit of Measure: Number and proportion of patients completing sessions (%). Adherence will also be evaluated using patient-reported outcomes collected through the Activiti® application and APA professional assessments, including the number of APA sessions performed and APA dose intensity.
Inclusion, week 4, week 8, week +1, week +5, week +9
Pancreatic function assessment
Time Frame: week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Fecal elastase and pancreatic enzyme use will be assessed. Unit of Measure: Levels of fecal elastase (µg/g) and pancreatic enzyme consumption (units/day).
week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Surgical rate assessment
Time Frame: Surgery and postoperative period
Surgical rate will be assessed. Unit of Measure: Number/proportion of patients with surgery
Surgery and postoperative period
Nutritional Status Assessment - Body composition
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Evaluating changes in skeletal muscle and fat mass to assess nutritional status during the prehabilitation program. Outcome Measure: Skeletal muscle and adipose tissue areas. Unit of Measure: cm² (cross-sectional area at L3 via TAP-CT or bioimpedance)
Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - weight and BMI
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Evaluating changes in body weight and BMI to monitor nutritional status. Unit of Measure: kg (weight), kg/m² (BMI).
Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Food intake
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Measuring dietary intake and eating behavior to assess nutritional status. Unit of Measure: Simple Evaluation of Food Intake (SEFI) visual analog scale. The score is reported using the SEFI visual analog scale, which ranges from 0 to 10, where higher scores indicate better food intake.
Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Serum Albumin evaluation
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)

Evaluating nutritional status through Serum Albumin evaluation. Unit of Measure: g/L. Meaning: Higher albumin levels indicate better nutritional status and overall protein reserves.

Interpretation:

Good: Higher values (within normal laboratory range) Bad: Lower values (may indicate malnutrition or poor protein intake)
Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - C-Reactive Protein (CRP) evaluation
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)

Evaluating inflammatory status through CRP levels. Unit of Measure: mg/L. CRP is a marker of inflammation. Lower CRP indicates lower inflammatory activity.

Interpretation:

Good: Lower values (normal or near-normal, minimal inflammation) Bad: Higher values (indicating active inflammation or possible infection)
Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Nutritional Status Assessment - Complete Blood Count (CBC) Parameters evaluation
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)

Description: Evaluating general health and nutritional status through CBC parameters (e.g., hemoglobin, hematocrit, leukocytes). Unit of Measure: Standard laboratory units (e.g., g/dL for hemoglobin, cells/µL for leukocytes). Meaning: CBC evaluates general health and nutritional status (e.g., hemoglobin for anemia, leukocytes for immune status).

Interpretation:

Good: Values within normal reference ranges Bad: Values outside normal ranges (e.g., low hemoglobin = anemia, abnormal leukocytes = possible infection or immune dysfunction)
Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years)
Functional Status Assessment - Behavioral changes in physical activity (International Physical Activity Questionnaire [IPAQ-S])
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months)
Assessing daily physical activity using IPAQ-S. It is a 7-item questionnaire in which duration (hours and minutes per day), frequency (times per week), and intensity (walking, moderate and vigorous) of the previous 7 days will be collected. Sedentary time (self-reported time spent sitting) in the same time period will be recorded (hours/min/day).Unit of Measure: MET-min/week and Minutes/day.
Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months)
Functional Status Assessment - 6-minute walk test
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Assessing functional exercise capacity. Outcome Measure: Walking distance (meters).
Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Handgrip strength
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Assessing upper body muscle strength. Unit of Measure: Kilograms (kg)
Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Sit-to-stand test (STS)
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Measuring lower limb strength and functional capacity. Unit of Measure: Repetitions per minute
Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Borg scale
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Measuring subjective exertion during functional tests. Unit of Measure: Score. Score on the Borg scale ranges from 6 (no exertion) to 20 (maximal exertion). Lower scores indicate lighter effort (better functional tolerance), higher scores indicate greater perceived exertion (more strain).
Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Balance
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Measuring balance and stability. Unit of Measure: Seconds
Inclusion, week 4, week 8, week +1, week +5, week +9
Functional Status Assessment - Time Up and Go (≥70 years)
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9
Measuring mobility and fall risk in older patients. Unit of Measure: Seconds
Inclusion, week 4, week 8, week +1, week +5, week +9
Hospital Anxiety and Depression Scale (HADS) assessment
Time Frame: Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months)
The HADS is a 14-item questionnaire assessing anxiety through 7 items and depression with 7-items. One score is generated per dimension on a 0-21 scale with the sum of the corresponding items. A score between 0 and 7 represents the absence of anxiety/depression. More of 9 in HADS-anxiety (A) is considered as a presence of an anxiety disorder which needs the intervention of a psychologist (anxiety) and more of 7 in HADS-depression (D) is considered as a presence of depression disorder which needs the intervention of a psychiatrist (depression).
Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory outcome measure - Changes in imaging assessment
Time Frame: Baseline to preoperative assessment
Comparing baseline imaging with preoperative imaging to assess changes in body composition and tumor characteristics, stratified by completion of the prehabilitation program. Unit of Measure: cm² for body composition, mm or cm³ for tumor size
Baseline to preoperative assessment
Exploratory outcome measure - Changes in tumor specimen
Time Frame: At surgery
Evaluating differences between baseline diagnostic biopsy and resected surgical specimen for each patient, stratified by completion of the prehabilitation program. Unit of Measure: Pathologic features (categorical or qualitative).
At surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cindy Neuzillet, MD, Institut Curie, Saint-Cloud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POP-UP G-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings